Label: HIGHMARK- alcohol liquid
- NDC Code(s): 63148-402-08, 63148-402-32
- Packager: Apollo Health and Beauty Care
- 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 June 24, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- Directions
- Inactive Ingredients
- Questions
- Principal Display Panel 8 FL OZ
- Principal Display Panel 32 FL OZ
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INGREDIENTS AND APPEARANCE
HIGHMARK
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BASIC BLUE 1 (UNII: 92N74OA24D) GLYCERIN (UNII: PDC6A3C0OX) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOPROPYL ALCOHOL (UNII: ND2M416302) BASIC YELLOW 5 (UNII: 07BP340B4T) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-402-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2023 2 NDC:63148-402-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2023 Labeler - Apollo Health and Beauty Care (201901209) Registrant - Apollo Health and Beauty Care (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care 201901209 manufacture(63148-402)