Risk Category of Japanese OTC Drugs

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1st Level  2nd Level  3rd Level  4th Level  5th Level 

 Drugs requiring guidance
 
 First-class OTC drugs
 
 Designated second-class OTC drugs
 
 Second-class OTC drugs
 
 Third-class OTC drugs
   Inorganic and organic chemicals
     Zinc oxide starch powder
     Zinc oxide
     Acrinol hydrate
     Acriflavine
     Acidophilus
     Ascorbic acid
     L-Aspartic acid
     Aspergillus oryzae NK
     Aspergillus oryzae fat digestive enzyme
     Azulene
     Sodium gualenate hydrate
     Ethyl aminobenzoate
     Aminoethylsulfonic acid; Taurine
     Epsilon-Aminocaproic acid
     Amylase
     Amylolisin; Bacillus subtilis amylose digestive enzyme
     L-Alanine
     Allantoin
     Alimemazine
     L-Arginine
     Alkyldiaminoethylglycine hydrochloride
     Alkylpolyaminoethylglycine hydrochloride
     Alcloxa
     Algae colloid
     Aldioxa
     Aloin
     Benzoic acid
     Caffeine and sodium benzoate
     Ammonia solution, strong
     Foeniculated ammonia spirit
     Sulfur
     Ichthammol
     Isothipendyl
     Isopropanol
     L-Isoleucine
     Inositol
     Inositol hexanicotinate
     Ursodeoxycholic acid
     Undecylenic acid
     Ethanol
     Ergocalciferol
     Zinc chloride
     Ammonium chloride
     Potassium chloride
     Calcium chloride
     Sodium chloride
     Eugenol
     Oxycholanic acid
     Oxo amidine
     Oxo resin
     Octotiamine
     Alkylpolyaminoethylglycine - polyoxyethylenealkylphenyl ether mixt
     2-omega-[5'-bromopyridyl-(2')-amino]-vinyl-6-methylpyridine iodine isoamylate
     2-omega-[5'-bromopyridyl-(2')-amino]-vinyl-6-methylpyridine iodine etylate
     gamma Oryzanol
     Olipase
     Orotic acid
     Oxydol
     Gastric mucin
     Anhydrous caffeine
     Capsaicin
       D00250  Capsaicin (JAN/USP)
     Galactose
     Calamine
     Potash soap
     Carnitine
     Carbazochrome
     Carpronium chloride
     Carmellose
     Dried yeast
     dl-Camphor
     Absorptive ointment
     1,4-Dimethyl-7-isopropylazulene
     Sodium gualenate
     Guaifenesin
     Anhydrous citric acid
     Choline dihydrogen citrate
     Glycine
     Glycerin
     Glycerin and potash solution
     Calcium glycerophosphate
     Glycyrrhizin
     Glycyrrhizin
     Glycyrrhetinic acid
     Cryptocyanine O.A. complex
     Glucuronolactone
     Sodium glucuronate hydrate
     Glucuronamide
     Calcium gluconate
     L-Glutamine
     Glutamic acid
     Crocetin
     Crotamiton
     Chlorohydroxy alminum
     Chlorphenamine
     Chlorophyllin
     Chlorobutanol
     Synthetic aluminum silicate
     Magnesium silicate
     Gefarnate
     Cholic acid
     Choline
     Choline orotate
     Collodion
     Streptococcus faecalis
     Conzym
     Chondroitin sulfate A
     Acetic acid
     Aluminum acetate
     Sacrophyl
     Ethylene glycol salicylate
     Glycol salicylate
     Phenyl salicylate (external use only)
     Methyl salicylate
     Monoglycol salicylate
     Zinc oxide
     Magnesium oxide
     Sancron
     Samprose; Rhizopus chinensis digestive enzyme
     Diastase
     Diasmin
     Cyanocobalamin
     Diisopropylamine dichloroacetate
     Cycotiamine hydrochloride
     Bismuth subnitrate
     Cystine
     L-Cysteine
     Dicethiamine
     Diphenylimidazole
     Diphenylpyraline
     Diphenhydramine
     Dibenzoyl thiamine
     Bismuth subgallate
     Dimeticone
     Dimethylaminoethyl salicylate
     1,4-Dimethyl-7-isopropylazulene
     Dimethylpolysiloxane
     Dimemorfan
     Potassium hydrogen tartrate
     Potassium nitrate
     Hydrophilic ointment
     Calcium hydroxide
     Magnesium hydroxide
     Pancreatic digestive enzyme
     Stearic acid
     Cetylpyridinium
     Camphor soap
     Cetraxate
     Cepharanthine
     Semi-alkaline proteinase
     Gelatin
     Serrapeptase
     Cellulase
     Cellulocin
     Cellulose
     Soysterol
     D-Sorbitol
     Soysterol
     Salivary glands hormone
     Takadiastase
     Talc
     Precipitated calcium carbonate
     Sodium bicarbonate
     Sodium carbonate
     Magnesium carbonate
     Simple ointment
     Tannic acid
     Thiamine
     Thiamine disulfide
     Thiamine dicetylsulfate
     Thianthol
     Thioctic acid
     Thioctic acid amide
     Thymol
     Zinc oxide oil
     Dequalinium chloride
     Dehydrocholic acid
     Sodium dehydroacetate
     Starch
     Amylolytic bacillus
     Copper chlorophyllin
     Tocopherol
     Tocopherol calcium succinate
     Tocopherol acetate
     Domiphen bromide
     Tranexamic acid
     Triclocarban
     Trichlorocarbanilide
     L-Tryptophan
     Tribromophenyl caproate
     L-Threonine
     Tretinoin tocoferil
     Nagarse; Bacillus subtilis protease
     Natto bacillus
     Nicotinic acid
     Nicotinamide
     Benzyl nicotinate
     Lactic acid
     Zinc lactate
     Calcium lactate
     Spore forming lactic acid bacteria
     Newlase
     Urea
     Selenium sulfide
     Neostigmine
     Noscapine
     Nonanoic acid vanillylamide
     White ointment
     White soft sugar
     Platinum
     Palladium
     diethylaminoethyl p-butylaminobenzoate hydrochloride
     L-Valine
     Pancreatin
     Pantethine
     Panthenol
     Pantothenyl ethylether
     Pantothenic acid
     Panprosin
     Hyaluronic acid
     Biotamylase
     Biodiastase; Aspergillus oryzae digestive enzyme
     Biodiasmin
     Biotin
     Bionattomin; Bacillus subtilis digestive enzyme
     Biolactis
     Bisibuthiamine
     Bisthiamine
     L-Histidine
     Bisbentiamine
     Vitamin A oil
     Bithionol
     Pityrol
     Hydroxyethyl cellulose
     Hydroxypropylcellulose
     Hydroxypropylmethyl cellulose
     Hinokitiol
     Bifidobacterium
     Pargyline
     Pyridoxine hydrochloride
     Pyridoxine palmitate
     Pyr methylphenol
     Pyroxylin
     Hylodase
     Phytin
     Streptococcus faecalis
     L-Phenylalanine
     Phenyliodoundecynoate
     Diethyl phthalate
     Sodium fluoride
     Wine
     Glucose
     Flavin adenine dinucleotide
     Fursultiamine
     Prozyme
     Prosultiamine
     Protamylase
     Protease
     Bromelain
     Hespitan
     Hesperidin
     Betaine
     Hepronicate
     Coptis rhizome
     Benzalkonium chloride
     Benzyl alcohol
     Benzethonium chloride
     Benzoylthiamine disulphide
     Benfotiamine
     Boric acid
     Phosphorylcholine
     Povidone-Iodine
     Polyenephosphatidyl choline
     Polipase
     Polyvinyl alcohol
     Polyvinylpyrrolidone
     Polybutene
     Borneol
     Macrogol ointment
     Mamitase
     Water
     Mecobalamin
     Methanol denatured alcohol
     Methionine
     Mthyl isopropylphenol
     Methylcellulose
     Methyl hesperidin
     Methylmethionine sulfonium chloride
     Methylrosanilinium chloride
     Methylthymol tannin
     Methylene blue
     Menthol
     Menfegol
     Pine tar
     Sodium monofluorophosphate
     Morusin
     Organic sulfur containing compound
     Ubidecarenone
     Potassium iodide
     Folic acid
     Iodine
     Yolk lecithin
     Iodine tincture
     Lauryl aminoethyl glycine
     Lauromacrogol
     Clostridium butyricum
     Lactomin
     Lacbon
     Lacb
     Licocymin
     Licorex
     Lysine
     Lysozyme hydrochloride
     Linoleate
     Lipase
     Riboflavin
     Riboflavin butyrate
     Riboflavin sodium phosphate
     Calcium sulfide
     Zinc sulfate
     Aluminum potassium sulfate hydrate
     Sodium sulfate S 35
     Magnesium sulfate hydrate
     Malic acid
     Dibasic calcium phosphate
     Sodium phosphate, dibasic
     Potassium phosphate, monobasic
     Sodium dihydrogen phosphate
     Phospholipid
     Rutin
     Lecithin
     Vitamin A
     Retinol acetate
     Retinol palmitate
     L-Leucine
     Scopolia extract
     Scopolia extract and tannic acid suppositories
     Vaseline
   Crude drugs
OTC drugs that contain as active ingredients the substances listed above including their hydrates and salts
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Last updated: September 26, 2017
English translation by the Kanehisa Laboratories

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