AFASSCO 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 wash hands without water

Uses

for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available.

Warnings

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire or flame

Keep out of the reach of children.

If contact with eyes occurs rinse thoroughly with water.

If irritation or redness develops consult a physician.

When using this product

keep out of eyes.

consult a physician

if irritation or redness develops

Keep out of reach of children.

keep out of the reach of children

Directions

for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available.

Inactive Ingredients

purified water, glycerine, carbomer, aloe essence

Product Labeling

Hand Sanitizer

AFASSCO HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71734-206
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71734-206-01	2 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/18/2018

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

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

Name	Address	ID/FEI	Business Operations
Establishment
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	manufacture(71734-206)