ANTIBACTERIAL HAND SANITIZER APPLE BLAST SCENTED- 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

For external use only.

Flammable- Keep produt 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.

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 Crosspolymer, 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

ANTIBACTERIAL HAND SANITIZER APPLE BLAST SCENTED 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-065
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)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
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:56136-065-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/21/2020
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-065)

Revised: 7/2020
Document Id: 3752289a-71fb-45c2-a6ba-a473b53d774e
Set id: 4fd44795-b975-4965-b9cd-88d08b4790e4
Version: 1
Effective Time: 20200721
 
Ganzhou Olivee Cosmetic Co., Ltd.