PURE LABEL ADVANCED HAND SANITIZER GEL PLUS(ETHANOL)- alcohol gel 
EVERCOS CO. LTD.

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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EVERCOS CO. LTD. - PURELABEL ADVANCED HAND SANITIZER GEL PLUS 500ml

Alcohol

water, carbomer, triethanolamine, etc

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

keep out of reach of the children

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.

For external use only. Flammable. Keep away from heat or flame.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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.

for external use only

label

PURE LABEL ADVANCED HAND SANITIZER GEL PLUS(ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74437-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74437-0004-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/09/2020
Labeler - EVERCOS CO. LTD. (688318260)
Registrant - EVERCOS CO. LTD. (688318260)
Establishment
NameAddressID/FEIBusiness Operations
EVERCOS CO. LTD.688318260manufacture(74437-0004) , label(74437-0004) , pack(74437-0004)

Revised: 4/2020
Document Id: a2da997a-fbb3-9ded-e053-2a95a90abce2
Set id: 70f67b95-d8b6-4c47-bb5f-e9ed6114ada8
Version: 1
Effective Time: 20200409
 
EVERCOS CO. LTD.