ANTIBACTERIAL HNAD 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

decrease bacteria and germs on the hands
use when soap , towel and water are not available.
recommended for repeared use.

Warnings

For external use only.

Stop use and ask a doctor ifirritation or redness develops or persists.

Flammable, keep away from fire or flame

Do not apply around eyes.

Do not use in ears and mouth

Other information:

store at 20℃ (68 to 77 ℉)
may discolor fabrics

avoid contact with eyes. In case of contact flush eyes with water

consult a physicia

if irritation or redness develops or persists

Keep out of reach of children.

Children under 6, use only under adult supervision. Not recommended for infants.

Directions

open the package, squeeze hand sanitizer into your palms and thoroughly spread on both hands
rub into skin until dry

Inactive Ingredients

purified water, triethanolamine, glycerine, Disodium EDTA, carbomer

Product Labeling

Hand Sanitizer

ANTIBACTERIAL HNAD SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71734-312
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71734-312-01	3 mL in 1 DOSE PACK; Type 0: Not a Combination Product	06/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/16/2020

Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)

Name	Address	ID/FEI	Business Operations
Establishment
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	manufacture(71734-312)