GINGERBREAD- antibacterial hand sanitizer gel

Gingerbread by

Drug Labeling and Warnings

Gingerbread by is a Otc medication manufactured, distributed, or labeled by Brands International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GINGERBREAD ANTIBACTERIAL HAND SANITIZER

ACTIVE INGREDIENT: ETHYL ALCOHOL 62% PURPOSE ANTISEPTIC

ANTISEPTIC

USES: TO DECREASE BACTERIA ON THE SKIN AND CLEAN HANDS. RECOMMENDED FOR REPEATED USE

WARNING: FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

DO NOT GET INTO EYES. IF CONTACT OCCURS,RINSE THROUGHLY WITH WATER.

DISCONTINUE USE IF IRRITATION OR REDNESS DEVELOP. IF IRRITATION PERSISTS FOR MORE THEN 72 HOURS, CONSULT A DOCTOR.

SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT.

DOSAGE & ADMINISTRATION

OTHER INFORMATIONMAY DISCOLOR CERTAIN FEBRICS OR SURFACES.

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

INGREDIENTS AND APPEARANCE

GINGERBREAD 
antibacterial hand sanitizer gel

Product 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)