HAND SANITIZER- ethyl alcohol gel 
WAG LABS, 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%

Purpose

Antibacterial

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Stop use and ask a doctor if irritation or rash develops and continues for more that 72 hours.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6 use only under adult supervision. Not recommended for infants.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanoamine

Other Information

Do not store above 105F. May discolor some fabrics. Harmful to wood finishes and plastics

Uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71828-001
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71828-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/01/2017
Labeler - WAG LABS, INC. (079601283)

Revised: 11/2017
Document Id: 5ce721cf-47b9-3cac-e053-2a91aa0adf13
Set id: 5ce721cf-47b8-3cac-e053-2a91aa0adf13
Version: 1
Effective Time: 20171101
 
WAG LABS, INC.