Label: GINGERBREAD- antibacterial hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50157-103-01 - Packager: Brands International
- 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 January 25, 2016
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- GINGERBREAD ANTIBACTERIAL HAND SANITIZER
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHEROL ACETATE (VITAMIN E), SUNFLOWER (HELIANTHUS ANNUUS) SEED EXTRACT, RED 40 (Cl 16035), Yellow 5 (Cl 19140), Blue 1 (Cl 42090)
- GINGERBREAD ANTIBACTERIAL HAND SANITIZER
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INGREDIENTS AND APPEARANCE
GINGERBREAD
antibacterial hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 620 mL in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-103-01 29 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 10/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2015 Labeler - Brands International (243748238) Establishment Name Address ID/FEI Business Operations Brands International 243748238 manufacture(50157-103)