Label: SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM- lidocaine, menthol cream
- NDC Code(s): 49873-619-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 30, 2022
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INGREDIENTS AND APPEARANCE
SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM
lidocaine, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-619 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49873-619-01 1 in 1 CARTON 11/14/2018 1 100 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 not final part348 11/14/2018 Labeler - Sato Pharmaceutical Co., Ltd. (690575642) Establishment Name Address ID/FEI Business Operations Sato Pharmaceutical Co., Ltd. 715699133 pack(49873-619) , label(49873-619) , manufacture(49873-619)