Label: GUARD- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 63148-622-10, 63148-622-20, 63148-622-30, 63148-622-40, view more63148-622-50, 63148-622-60, 63148-622-70 - Packager: Apollo Health and Beauty Care 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 27, 2020
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
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- Principal Display Panel 2 oz
- Principal Display Panel 8 oz
- Principal Display Panel 15 oz
- Principal Display Panel 32 oz
- Principal Display Panel 40 oz
- Principal Display Panel 64 oz
- Principal Display Panel 128 oz
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INGREDIENTS AND APPEARANCE
GUARD
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 700 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-622-10 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 2 NDC:63148-622-20 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 3 NDC:63148-622-30 444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 4 NDC:63148-622-40 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 5 NDC:63148-622-50 1182 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 6 NDC:63148-622-60 1892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 7 NDC:63148-622-70 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/23/2020 Labeler - Apollo Health and Beauty Care Inc (201901209) Registrant - Apollo Health and Beauty Care Inc (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc 201901209 manufacture(63148-622)