ANTI-BAC HAND SANITIZER MIXED BERRIES 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

Ethyl Alcohol 65% 

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.

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).

No Animal Testing

Packaging

image description

ANTI-BAC HAND SANITIZER MIXED BERRIES SCENTED 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-431
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 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:56136-431-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/18/2020
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-431)

Revised: 10/2020
Document Id: 6d1cdca1-5bf8-4dec-a204-11e0ac579547
Set id: a8dd68f0-90db-40e1-9b4b-2dd492f62d5a
Version: 1
Effective Time: 20201018
 
Ganzhou Olivee Cosmetic Co., Ltd.