PURENIQUE HYGIENE SOLUTIONS HAND SANITIZER- alcohol liquid 
JIANGMEN SHUIZIRUN SANITARY ARTICLES 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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Drug Fact

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Warnings

For external use only. Avoid contact with the wound. Do not allow this product to come into contact with eyes or nearby.

If you accidently touch a wound or eye, rinse immediately with water.

If skin irritation or sensitivity occurs ,discontinue use and consult your doctor immediately.

Not recommended for infants.

Other information:

Store at 20℃(68 to 77 ℉)in a cool place . May discolor fabrics.

Keep out of reach of children.

Do not allow children under 6 years of age to handle or apply this product,If swallowed ,contact your doctor immediately.

Directions

No water needed . Apply a small amount of product to dry skin.

Inactive Ingredients

Pure Water, Glycerine, Carbomer, Triethanolamine, Disodium EDTA

Product Labeling

Hand Sanitizer

PURENIQUE HYGIENE SOLUTIONS HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-329
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71734-329-015 mL in 1 DOSE PACK; Type 0: Not a Combination Product09/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/2020
Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
Establishment
NameAddressID/FEIBusiness Operations
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534manufacture(71734-329)

Revised: 9/2020
Document Id: 46223c18-270a-4e42-948f-0ece4009cebc
Set id: 4f4ab6a2-e3f3-4be4-b91d-18b81f7fc624
Version: 1
Effective Time: 20200925
 
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.