HAND SANITIZER- ethyl alcohol gel 
Novelty Creative Solutions, 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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Active Ingredient:
Ethyl Alcohol 62% V/V

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Directions

Pump as needed into your palms to cover hands. Rub hands together brisky unitl dry. Children under 6 years old should be supervised when using this product.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, PPG-30 Cetyl Ether, PEG-40 Hydrogenated Castor Oil

Other Information Store below 118 F.

Uses

To help reduce bacteria on the skin.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72180-001
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
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PPG-30 CETYL ETHER (UNII: 00C2W8NVII)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72180-001-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/25/2018
Labeler - Novelty Creative Solutions, Inc. (036326587)

Revised: 3/2018
Document Id: 68349e28-ba78-344f-e053-2a91aa0a3932
Set id: 68349e28-ba77-344f-e053-2a91aa0a3932
Version: 1
Effective Time: 20180324
 
Novelty Creative Solutions, Inc.