CANDY COATED APPLE ANTI-BACTERIAL SCENTED 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

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

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

CANDY COATED APPLE ANTI-BACTERIAL SCENTED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-358
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:56136-358-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/29/2020
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-358)

Revised: 6/2020
Document Id: 5e900563-2079-467a-8a1b-31e6634ce53b
Set id: 58dfe57d-9eac-435a-b43c-78986991bf55
Version: 1
Effective Time: 20200629
 
Ganzhou Olivee Cosmetic Co., Ltd.