SANITIZING WIPES- benzalkonium chloride,didecyldimonium chloride cloth
SHANGHAI SANJUN GENERAL MERCHANDISE 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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75670-001 esteem sanitizing wipes

Active Ingredient

Benzalkonium Chloride 0. 1 %
Didecyldimonium Chloride 0.1 5%

Purpose

Antiseptic
Antiseptic

USE

For cleaning & disinfecting hand
Dries in seconds
Perfect for use in the home,office and on the go.

Warning

For external use only
May irritate eyes

Keep out of reach of children unless under
adult supervision

Directions

Peel back seal
Dispense wipe and clean
Close seal after use to prevent drying out
Do not flush into toilet
After use, dispose of wipe in bin

Inactive ingredients

Bronopol;Ethylhexylglycerin;
Propylene Glycol;Glycerin;Purified Water

SANITIZING WIPES
benzalkonium chloride,didecyldimonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75670-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BRONOPOL (UNII: 6PU1E16C9W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75670-001-01	24 in 1 CARTON	05/20/2020
1		100 in 1 PAIL
1		0.0078 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:75670-001-02	12 in 1 CARTON	05/20/2020
2		100 in 1 PAIL
2		0.0078 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:75670-001-03	24 in 1 CARTON	05/20/2020
3		100 in 1 BAG
3		0.0078 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:75670-001-04	12 in 1 CARTON	05/20/2020
4		100 in 1 BAG
4		0.0078 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/20/2020

Labeler - SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD. (527500109)

Name	Address	ID/FEI	Business Operations
Establishment
SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD.		527500109	manufacture(75670-001)