HAND SANITIZER- ethyl alcohol gel 
Germ Guards Incorporated

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
Antimicrobial

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use in or near eyes. If eye contact occurs, flush thoroughly with water and seek medical care.

Avoid contact with broken skin.

Ingestion may cause alcohol poisoning. If ingested, contact a physician or local poison control center.

Stop use and seek medical attention if irritation or redness occurs.

Keep out of reach of children.

Directions

Inactive Ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

Uses

Other Information

Store below 110 F/43 C

image of bottle label

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71089-002
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)  
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:71089-002-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/09/2017
Labeler - Germ Guards Incorporated (080329404)
Registrant - Germ Guards Incorporated (080329404)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(71089-002)

Revised: 6/2017
Document Id: 50e66bbc-a4b3-501d-e054-00144ff8d46c
Set id: 4f188d59-f854-3f99-e054-00144ff88e88
Version: 2
Effective Time: 20170601
 
Germ Guards Incorporated