Label: GEL HAND SANITIZER WINTERGREEN- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75660-124-01, 75660-124-04, 75660-124-05, 75660-124-06, view more75660-124-08, 75660-124-16, 75660-124-25, 75660-124-44 - Packager: Sovents and Petroleum Inc
- 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 October 13, 2020
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- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
GEL HAND SANITIZER WINTERGREEN
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75660-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) 0.5 mL in 100 mL DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.01 mL in 100 mL GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.35 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.18 mL in 100 mL WATER (UNII: 059QF0KO0R) 30.95 mL in 100 mL POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 2 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75660-124-01 3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/13/2020 2 NDC:75660-124-04 4 in 1 BOX 10/13/2020 2 NDC:75660-124-01 3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:75660-124-05 18927.05 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/13/2020 4 NDC:75660-124-06 6 in 1 BOX 10/13/2020 4 NDC:75660-124-01 3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:75660-124-44 118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/13/2020 6 NDC:75660-124-08 236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/13/2020 7 NDC:75660-124-16 473.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/13/2020 8 NDC:75660-124-25 9463.52 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/13/2020 Labeler - Sovents and Petroleum Inc (013277454) Establishment Name Address ID/FEI Business Operations Clean All 117505240 manufacture(75660-124)