Label: GEL HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80242-100-01, 80242-100-02, 80242-100-03, 80242-100-04, view more80242-100-05, 80242-100-06, 80242-100-07 - Packager: 5 Peaks Products, LLC
- 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 September 12, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
GEL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80242-100 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 .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SQUALANE (UNII: GW89575KF9) RAPIDGEL EZ1 (UNII: 33JH4A7R2K) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80242-100-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 09/01/2020 2 NDC:80242-100-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 3 NDC:80242-100-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 4 NDC:80242-100-04 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 5 NDC:80242-100-05 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 6 NDC:80242-100-06 208000 mL in 1 DRUM; Type 0: Not a Combination Product 09/01/2020 7 NDC:80242-100-07 1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - 5 Peaks Products, LLC (117631506) Registrant - 5 Peaks Products, LLC (117631506)