HIBISCUS COCONUT HAND SANITIZER - alcohol solution 
Brands International

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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Hibiscus Coconut Hand Sanitizer

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

Directions

Other information

Inactive ingredients

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

Manufactured by:

Brands International Corp.
Markham, ON, L6G 1B9 Canada
www.brandsicorp.com

Package Label

HIBISCUS COCONUT

ANTIBACTERIAL

Hand Sanitizer Gel


Kills 99.99% of Germs
1 FL OZ (29 ml)

Label

HIBISCUS COCONUT HAND SANITIZER  
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-105
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-105-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/20/2015
Labeler - Brands International (243748238)

Revised: 4/2015
Document Id: 14479bd7-1d11-551f-e054-00144ff8d46c
Set id: ec78d441-bbf8-4dac-a9e0-8fdc3d5c82a9
Version: 1
Effective Time: 20150421
 
Brands International