AMERIGEL HAND SANITIZER- ethyl alcohol 70% gel 
Amerx Health Care Corp

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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Amerigel Hand Sanitizer

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on skin when soap and water are not available.

Warnings

For External Use only. Flammable. Keep away from heat or flame.

Do not use


In children less than 2 months of age. On open skin wounds.

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

­­­­­­­­­­­­­­­­­­­Stop use and ask a doctor.

If irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

­­­­­­­­­­­­­­­­­­­­­Directions

Wet hands thoroughly with product. Rub hands together briskly until dry. Supervise children under 6 years of age when using this product.

Other Information

Store below 110F (43C)

Inactive Ingredients

Water, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, PEG-8 Dimethicone, Triisopropanolamine, Linalool, FD&C Blue #1

Amerigel Hand Sanitizer

labellabel

AMERIGEL HAND SANITIZER 
ethyl alcohol 70% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61470-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL123.9 mL  in 177 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
PROPYLENE GLYCOL BUTYL ETHER (UNII: 6X8776AP5Z)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61470-001-12177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Amerx Health Care Corp (836425694)
Registrant - Amerx Health Care Corp (836425694)

Revised: 6/2020
Document Id: a8b2a1f2-b776-5f9d-e053-2a95a90a9065
Set id: a8b2a1f2-b775-5f9d-e053-2a95a90a9065
Version: 1
Effective Time: 20200622
 
Amerx Health Care Corp