GINGERBREAD HOUSE SCENTED ANTI-BACTERIAL HAND SANITIZER- alcohol gel 
Ganzhou Olivee Cosmetic Co., Ltd.

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.

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HAND SANITIZER

Drug Facts

Active ingredient

Alcohol ...... 62% 

Purpose

 Antiseptic

Use

Decrease bacteria on hands.

Warnings

For external use only.

Flammable - Keep product away from fire or flame.

When using this product

avoid contact with eyes; in case of contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops and persists.

Warning - Choking Hazard

Small Parts. Not for children under 3 years.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry.

Inactive ingredients

Water (Aqua), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSCOPOLYMER, AMINOMETHYL PROPANOL, Fragrance (Parfum), May contain: D&C Red No. 33 (Cl 17200), FD&C Red No. 4 (Cl 14700), FD&C Yellow No. 5 (Cl 19140), FD&C Blue No. 1 (Cl 42090).

Packaging

image description

GINGERBREAD HOUSE SCENTED ANTI-BACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-612
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
May containFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56136-612-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/20/2021
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-612)

Revised: 7/2021
Document Id: 678329d1-09ef-44da-aabe-7be3c0cf0e1e
Set id: b1e153cc-6005-4070-8ddd-f0ea5b589581
Version: 1
Effective Time: 20210720
 
Ganzhou Olivee Cosmetic Co., Ltd.