Label: TACT COOL JELLY- diphenhydramine hydrochloride, levomenthol gel
- NDC Code(s): 49873-704-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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INGREDIENTS AND APPEARANCE
TACT COOL JELLY
diphenhydramine hydrochloride, levomenthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-704 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 g LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) MONOETHANOLAMINE (UNII: 5KV86114PT) NONOXYNOL-9 (UNII: 48Q180SH9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49873-704-01 1 in 1 CARTON 10/02/1997 1 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 10/02/1997 Labeler - Sato Pharmaceutical Co., Ltd. (690575642) Establishment Name Address ID/FEI Business Operations Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-704) , label(49873-704) , pack(49873-704)