Label: GUARD- alcohol gel
- NDC Code(s): 63148-502-08
- 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 16, 2023
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- Active Ingredient
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- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
GUARD
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-502 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 ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) WATER (UNII: 059QF0KO0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL ALCOHOL (UNII: ND2M416302) ALOE VERA LEAF (UNII: ZY81Z83H0X) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-502-08 227 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 part333A 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(63148-502)