ANTIBACTERIAL HAND SANITIZER- alcohol gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol       62%

Purpose

 Antiseptic

Use

Hand sanitizer to help decrease bacteria on the skin.

When water, soap and towel are not available

Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame

Do not apply around eyes.

Do not use in ears and mouth.

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor If redness or irritation develop and persist for more than 72 hours

Keep out of reach of children.

children must be supervised in use of this product.

Directions

Pump as needed into your palms and thoroughly spread on both hands.

Rub into skin until dry.

Inactive ingredients

Pure Water, Triethanolamine, Glycerin, Disodium EDTA, Carbomer

SPL UNCLASSIFIED SECTION

Other Information

Store at 20 ℃  （68 to 77 ℉).

May discolor fabrics.

Packaging

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71734-309
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71734-309-01	54 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2020
2	NDC: 71734-309-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2020
3	NDC: 71734-309-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2020
4	NDC: 71734-309-04	238 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2020
5	NDC: 71734-309-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/02/2020

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

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

Establishment
Name	Address	ID/FEI	Business Operations
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	manufacture(71734-309)