HAND WIPES- chlorhexidine digluconate and benzethonium chloride cloth
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 FACTS

Active Ingredient

Benzethonium Chloride .......... 0.08

Chlorhexidine Digluconate ........ 0.10

Purpose

Cleaning

Uses:

Cleans and refreshes hands and face without soap and water

For external use only.

for external use on hands only.
Stop use and sonsult a doctor if skin irritation develops.
Store in a cool place.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Self-dries in seconds. Leaves skin soft and smooth.

Inactive Ingredients:

5-chloro-2-methyl-2H-isothiazol-3-one, Methylisothiazolinone, Polyaminopropyl Biguanide, Glycerol, Water

Principal Display Panel

HAND WIPES
chlorhexidine digluconate and benzethonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71734-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	0.1 g in 1 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.08 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
Water (UNII: 059QF0KO0R)
Methylisothiazolinone (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71734-203-01	13.3 g in 1 PACKAGE; Type 0: Not a Combination Product	10/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/09/2017

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(71734-203)