COCONUT ANTI BACTERIAL HAND SANITIZER- alcohol gel 
B2 Fashions Inc.

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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Coconut Anti-Bacterial Hand Sanitizer

Drug Facts

Active ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use

in ears & mouth

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 develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

Other information

Inactive ingredients

Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), FD&C Blue 1, D&C Red 33.

Package Labeling:

Label

COCONUT ANTI BACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71372-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71372-001-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/05/2017
Labeler - B2 Fashions Inc. (243904310)

Revised: 4/2017
Document Id: 4c6c2afd-17c3-2615-e054-00144ff8d46c
Set id: 4c6c2afd-17c0-2615-e054-00144ff8d46c
Version: 1
Effective Time: 20170405
 
B2 Fashions Inc.