Label: APHOGEE SERIOUS CARE AND PROTECTION REFRESHING HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54726-0000-1 - Packager: KAB Brands LLC.
- 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 May 19, 2020
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- PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
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INGREDIENTS AND APPEARANCE
APHOGEE SERIOUS CARE AND PROTECTION REFRESHING HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54726-0000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54726-0000-1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 05/01/2020 Labeler - KAB Brands LLC. (840521277) Establishment Name Address ID/FEI Business Operations KDC/ONE Cosmetic Laboratories of America Inc. 117449842 MANUFACTURE(54726-0000)