Action by the FDA

P92-27                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Sharon Snider - (301) 443-3285


    The Food and Drug Administration today proposed banning 415 ingredients   
from seven categories of nonprescription drugs because they have not been     
shown to be safe and effective for their stated claims. 
     The action affects a wide variety of nonprescription (OTC -- Over The    
Counter) products including remedies for digestive disorders, menstrual       
problems, fever blisters and poison ivy.  
    Use of most of the ingredients named has already been discontinued, but   
several products containing one or more of the ingredients remain on the      
market.  Manufacturers will have to reformulate or remove such products from  
the market before the proposed rules are published in final form and become   
effective.
    "We are taking this action because no proof has been submitted to FDA     
that shows the ingredients are effective for the conditions claimed," said    
FDA Commissioner David A. Kessler, M.D.
    The ban on some ingredients is not total, however; some ingredients       
banned for one use may be allowed for another.  For example, salicylic acid   
is being banned as an external pain reliever in insect bite and sting         
treatment drug products but has been found effective for removal of warts,    
corns and calluses.  In some cases ingredients known to be safe but which     
would not be allowed for certain claims could be used as inactive
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ingredients.  For example, peppermint, while not effective as a digestive     
aid, could be used as a flavoring agent.
    Most of the ingredients have been in use since before 1962, when a        
change in the law required that manufacturers submit proof of effectiveness   
for new drug products as well as drug products already on the market. To      
implement the part of the law dealing with nonprescription drugs, FDA set up  
a process to evaluate all ingredients contained in OTC drug products.  Since  
that review began, products and ingredients found harmful were removed from   
the market.  Products believed safe, but for which evidence of effectiveness  
was lacking, were allowed to remain in use until proof of their               
effectiveness could be finally established or until final rules, such as the  
one that will follow the proposal announced today, become effective.  
    In recently announced similar actions, FDA banned 223 ineffective         
ingredients from 19 categories of products in November 1990, and 111          
ineffective weight control ingredients in August 1991.
    The agency began reviewing ingredients contained in an estimated 300,000  
nonprescription drug products sold in this country in 1972.  Under the        
review, FDA evaluates reports prepared by advisory panels of outside experts  
together with comments from industry and the public.  It then publishes a     
proposed rule with another comment period which includes an opportunity for   
a public hearing.  Ultimately, FDA issues a final regulation (monograph)      
that is, in effect, a standard or recipe of acceptable ingredients, doses,    
formulations and instructions as well as permitted claims.
    Comments on the current proposal, published in today's Federal Register,  
may be sent within 60 days to: FDA Dockets Management Branch (HFA-305),       
12420 Parklawn Drive - Room 1-23, Rockvile, Md. 20857.
    A list of ingredients affected by this action is attached.
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                                      Page 3, P92-27, 415 Ingredients

                     Ingredients Covered by this Notice

     NOTE: If only one form of the ingredient is covered, this form appears   
in parentheses; i.e., "Myrrh (Fluid Extract)." 

(1)  Digestive Aid Drug Products:  Alcohol, Aluminum hydroxide,
Amylase, Anise Seed, Aromatic Powder, Asafetida, Aspergillus Oryza Enzymes,   
Bacillus Acidophilus, Bean, Belladonna Alkaloids, Belladonna Leaves           
(Powdered Extract), Betaine Hydrochloride, Bismuth Subcarbonate, Bismuth      
Subgallate, Black Radish Powder, Buckthorn, Calcium Gluconate, Capsicum,      
Capsicum (Fluid Extract), Carbon, Cascara Sagrada Extract, Catechu            
(Tincture), Catnip, Chamomile Flowers, Charcoal (Wood), Chloroform, Cinnamon  
Oil, Citrus Pectin, Cnicus benedictus (blessed thistle), Diastase, Diastase   
Malt, Dog Grass, Elecampane, Ether, Fennel Acid, Galega, Ginger, Glycine,     
Hectorite, Horsetail, Huckleberry, Hydrastis Canadensis (Golden Seal),        
Hydrastis Fluid Extract, Hydrochloric Acid, Iodine, Iron Ox Bile, Johnswort,  
Juniper, Kaolin (Colloidal), Knotgrass, Lactic Acid, Lactose, Lavender        
Compound (Tincture), Linden, Lipase, Lysine Hydrochloride, Mannitol,          
Mycozyme, Myrrh (Fluid Extract), Nettle, Nickel-Pectin, Nux Vomica Extract,   
Orthophosphoric Acid, Papaya (Natural), Pectin, Peppermint, Peppermint        
Spirit, Phenacetin, Potassium Bicarbonate, Potassium Carbonate, Protease,     
Prolase, Rhubarb Fluid Extract, Senna, Sodium Chloride, Sodium Salicylate,    
Stem Bromelain, Strawberry, Strychnine, Tannic Acid, Trillium, Woodruff.

(2)  Topical Antifungal Drug Products:

     A)  General Use - Alcloxa, Alum (Potassium), Aluminum Sulfate,           
Amyltricresols (Secondary), Basic Fuchsin, Benzethonium Chloride, Benzoic     
Acid, Benzoxiquine, Boric Acid, Camphor, Candicidin, Chlorothymol, Coal Tar,  
Dichlorophen, Menthol, Methylparaben, Oxyquinoline, Oxyquinoline Sulfate,     
Phenol, Phenolate Sodium, Phenyl Salicylate, Propionic Acid, Propylparaben,   
Resorcinol, Salicylic Acid, Sodium Borate, Sodium Caprylate, Sodium           
Propionate, Sulfur, Tannic Acid, Thymol, Tolindate, Triacetin, Zinc           
Caprylate, Zinc Propionate.

     B)  Diaper Rash Drug Products - Any ingredient(s) labeled with claims    
or directions for use in the treatment or prevention of diaper rash.

(3)  External Analgesic Drug Products:

     A)  Diaper Rash Drug Products - Any ingredient(s) labeled with claims    
or directions for use in the treatment or prevention of diaper rash.

     B)  Fever Blister and Cold Sore Treatment Drug Products - Allyl          
Isothiocyanate, Aspirin, Bismuth Sodium Tartrate, Camphor, Capsaicin,         
Capsicum, Capsicum Oleoresin, Chloral Hydrate, Chlorobutanol,                 
Cyclomethycaine Sulfate, Eucalyptus Oil, Eugenol, Glycol Salicylate,          
Hexylresorcinol, Histamine Dihydrochloride, Menthol, Methapyrilene            
Hydrochloride, Methyl Nicotinate, Methyl Salicylate, Pectin, Salicylamide,    
Strong Ammonia Solution, Tannic Acid, Thymol, Tripelennamine Hydrochloride,   
Trolamine Salicylate, Turpentine Oil, Zinc Sulfate.

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     C)  Insect Bite and Sting Drug Products - Alcohol, Alcohol
(Ethoxylated Alkyl), Benzalkonium Chloride, Calamine, Ergot
Fluidextract, Ferric Chloride, Panthenol, Peppermint Oil, Pyrilamine,         
Maleate, Sodium Borate, Trolamine Salicylate, Turpentine Oil, Zinc Oxide,     
Zirconium Oxide.

     D)  Poison Ivy, Poison Oak, and Poison Sumac Drug Products -
Alcohol, Aspirin, Benzethonium Chloride, Benzocaine (0.5 to 1.25
Percent), Bithionol, Calamine, Cetalkonium Chloride, Chloral Hydrate,         
Chlorobutanol, Chlorpheniramine Maleate, Creosote (Beechwood),                
Cyclomethycaine Sulfate, Dexpanthenol, Diperodon Hydrochloride, Eucalyptus    
Oil, Eugenol, Glycerin, Glycol Salicylate, Hectorite, Hexylresorcinol,
Hydrogen Peroxide, Impatiens Biflora Tincture, Iron Oxide, Isopropyl          
Alcohol, Lanolin, Lead Acetate, Merbromin, Mercuric Chloride, Methapyrilene   
Hydrochloride, Panthenol, Parethoxycaine Hydrochloride, Phenyltoloxamine      
Dihydrogen Citrate, Povidone-Vinylacetate Copolymers, Pyrilamine Maleate,     
Salicylamide, Salicylic Acid, Simethicone, Sulfur, Tannic Acid, Thymol,       
Trolamine, Turpentine Oil, Zirconium Oxide, Zyloxin.

(4)  Internal Analgesic Drug Products:  Aminobenzoic Acid, Antipyrine,        
Aspirin (Aluminum), Calcium Salicylate, Codeine, Codeine Phosphate, Codeine   
Sulfate, Iodoantipyrine, Lysine Aspirin, Methapyrilene Fumarate, Phenacetin,  
Pheniramine Maleate, Pyrilamine Maleate, Quinine, Salsalate, Sodium           
Aminobenzoate.

(5)  Orally Administered Menstrual Drug Products:  Alcohol, Alfalfa Leaves,   
Aloes, Asclepias Tuberosa, Asparagus, Barosma, Bearberry (Extract Of Uva      
Ursi), Bearberry Fluidextract (Extract Of Bearberry), Blessed Thistle         
(Cnicus Benedictus), Buchu Powdered Extract (Extract Of Buchu), Calcium       
Lactate, Calcium Pantothenate, Capsicum Oleoresin, Cascara Fluidextract,      
Aromatic (Extract Of Cascara), Chlorprophenpyridamine Maleate, Cimicifuga     
Racemosa, Codeine, Collinsonia (Extract Stone Root), Corn Silk, Couch Grass,  
Dog Grass Extract, Ethyl Nitrite, Ferric Chloride, Ferrous Sulfate, Gentiana  
Lutea (Gentian), Glycyrrhiza Glabra (Licorice Root), Homatropine              
Methylbromide, Hydrangea (Powdered Extract) (Extract Of Hydrangea),           
Hydrastis Canadensis (Golden Seal), Hyoscyamine Sulfate, Juniper Oil (Oil Of  
Juniper), Magnesium Sulfate, Methapyrilene Hydrochloride, Methenamine,        
Methylene Blue, Natural Estrogenic Hormone, Niacinamide, Nutmeg Oil (Oil Of   
Nutmeg), Oil Of Erigeron, Parsley, Peppermint Spirit, Pepsin (Essence),       
Phenacetin, Phenindamine Tartrate, Phenyl Salicylate, Piscidia Erythrina,     
Pipsissewa, Potassium Acetate, Potassium Nitrate, Riboflavin, Saw Palmetto,   
Senecio Aureus, Sodium Benzoate, Sodium Nitrate, Sucrose, Sulferated Oils Of  
Turpentine, Taraxacum Officinale, Theobromine Sodium Salicylate,              
Theophylline, Thiamine Hydrochloride, Triticum, Turpentine (Venice) (Venice   
Turpentine), Urea.

(6)  Pediculicide Drug Products:  Benzocaine, Benzyl Alcohol, Benzyl          
Benzoate, Chlorophenothane (Dichlorodiphenyltrichloroethane), Coconut Oil     
Soap (Aqueous), Copper Oleate, Docusate Sodium, Formic Acid, Isobornyl        
Thiocyanoacetate, Picrotoxin, Propylene Glycol, Sabadilla Alkaloids, Sulfur   
(Sublimed), Thiocyanoacetate.

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                                            Page 5, P92-27, 415 Ingredients

(7)  Skin Protectant Drug Products:

    A)  Astringent Drug Products -  Acetone, Alcohol, Alum
(Ammonium), Alum (Potassium), Aluminum Chlorhydroxy Complex,
Aromatics, Benzalkonium Chloride, Benzethonium Chloride, Benzocaine, Benzoic  
Acid, Boric Acid, Calcium Acetate, Camphor Gum, Clove Oil, Colloidal          
Oatmeal, Cresol, Cupric Sulfate, Eucalyptus Oil, Eugenol, Honey, Isopropyl    
Alcohol, Menthol, Methyl Salicylate, Oxyquinoline Sulfate,                    
P-T-Butyl-M-Cresol, Peppermint Oil, Phenol, Polyoxytheylene Laurate,          
Potassium Ferrocyanide, Sage Oil, Silver Nitrate, Sodium Borate, Sodium       
Diacetate, Talc, Tannic Acid Glycerite, Thymol, Topical Starch, Zinc          
Chloride, Zinc Oxide, Zinc Phenolsulfonate, Zinc Stearate, Zinc Sulfate.
    
    B)  Diaper Rash Drug Products - Aluminum Hydroxide, Cocoa Butter,         
Cysteine Hydrochloride, Glycerin, Protein Hydrolysate, Racemethionine,        
Sulfur, Tannic Acid, Zinc Acetate, Zinc Carbonate.

    C)  Fever Blister and Cold Sore Treatment Drug Products -
Bismuth Subnitrate, Boric Acid, Pyridoxine Hydrochloride, Sulfur,
Tannic Acid, Topical Starch, Trolamine, Zinc Sulfate.

    D)  Insect Bite and Sting Drug Products - Alcohol, Alcohol
(Ethoxylated Alkyl), Ammonia Solution (Strong), Ammonium Hydroxide,           
Benzalkonium Chloride, Camphor, Ergot Fluidextract, Ferric Chloride,          
Menthol, Peppermint Oil, Phenol, Pyrilamine Maleate, Sodium Borate,           
Trolamine, Turpentine Oil, Zirconium Oxide.

     E)  Poison Ivy, Poison Oak, and Poison Sumac Drug Products -
Alcohol, Anion And Cation Exchange Resins (Buffered), Benzethonium Chloride,  
Benzocaine, Benzyl Alcohol, Bismuth Subnitrate, Bithionol, Boric Acid,        
Camphor, Cetalkonium Chloride, Chloral Hydrate, Chlorpheniramine Maleate,     
Creosote, Diperodon Hydrochloride, Diphenhydramine Hydrochloride, Eucalyptus  
Oil, Ferric Chloride, Glycerin, Hectorite, Hydrogen Peroxide, Impatiens       
Biflora Tincture, Iron Oxide, Isopropyl Alcohol, Lanolin, Lead Acetate,       
Lidocaine, Menthol, Merbromin, Mercuric Chloride, Panthenol, Parethoxycaine   
Hydrochloride, Phenol, Phenyltoloxamine Dihydrogen Citrate,                   
Povidone-Vinylacetate Copolymers, Salicylic Acid, Simethicone, Tannic Acid,   
Topical Starch, Trolamine, Turpentine Oil, Zirconium Oxide, Zyloxin.

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