Label: HAND SANITIZER- alcohol gel
- NDC Code(s): 63148-632-02, 63148-632-08, 63148-632-10
- Packager: Apollo Health and Beauty Care
- Category: HUMAN OTC DRUG LABEL
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 April 5, 2022
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- Package Label - Principal Display Panel (NC 2OZ)
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- PDP 8 FL OZ
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-632 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 ISOPROPYL ALCOHOL (UNII: ND2M416302) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) BASIC BLUE 1 (UNII: 92N74OA24D) BASIC YELLOW 5 (UNII: 07BP340B4T) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-632-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2021 2 NDC:63148-632-10 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2021 3 NDC:63148-632-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/01/2021 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(63148-632)