KERMA HAND SANITIZER- ethyl alcohol gel 
MCCORD RESEARCH

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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KERMA HAND SANITIZER

Active lngredient  

Ethyl Alcohol

Purpose 

Antiseptic 

Uses 

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use 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 right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing

Other information

Store between 15-30°C (59-86F)

Avoid freezing and excessive heat above 40°C (104F)

Inactive Ingredients

Water, Fragrance, Carbomer, PEG-40 Hydrogenated Castor Oil, chlorphenesin, Aminomethyl Propanol

product Label

image description

KERMA HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71358-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71358-018-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - MCCORD RESEARCH (010011284)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development, LLC962452533manufacture(71358-018)

Revised: 1/2022
Document Id: d66df19e-04ca-a5c7-e053-2a95a90a7ca7
Set id: 297b1ff8-59bd-4a23-821a-b45d3aaad789
Version: 4
Effective Time: 20220125
 
MCCORD RESEARCH