ANTIBACTERIAL HAND SANITIZER HAWAIIAN COCONUT SCENTED WITH VITAMIN E AND ALOE VERA- 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 ............. 65% 

Purpose

 Antiseptic

Use

Decreases 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 redness or irritation 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 Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Packaging

image description

ANTIBACTERIAL HAND SANITIZER HAWAIIAN COCONUT SCENTED  WITH VITAMIN E AND ALOE VERA
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-387
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)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56136-387-01350 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/09/2020
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-387)

Revised: 7/2020
Document Id: a7f84438-b254-4c82-810f-503c8bc4b1fb
Set id: c6d4fe99-d852-4bf8-a78b-45518f2d067e
Version: 1
Effective Time: 20200709
 
Ganzhou Olivee Cosmetic Co., Ltd.