Label: AMEKINA INSTANT HAND SANITIZER GEL- alcohol gel
- NDC Code(s): 43595-122-47, 43595-122-89
- Packager: Angelini Pharma Inc.
- 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 November 3, 2022
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- amekina Instant Hand Sanitizer Gel 6047 Drug Facts and Label
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INGREDIENTS AND APPEARANCE
AMEKINA INSTANT HAND SANITIZER GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43595-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER 934 (UNII: Z135WT9208) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) DIISOPROPYLAMINE (UNII: BR9JLI40NO) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43595-122-89 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/03/2022 2 NDC:43595-122-47 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/03/2022 Labeler - Angelini Pharma Inc. (078843940) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(43595-122)