DISINFECTING WIPES- benzalkonium chloride,didecyl dimethyl ammonium chloride cloth

DISINFECTING WIPES by

Drug Labeling and Warnings

DISINFECTING WIPES by is a Otc medication manufactured, distributed, or labeled by CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DISINFECTING WIPES

Active Ingredient(s)

Benzalkonium Chloride 0.2g/100g
DiDecyl dimethyl ammonium chloride 0.2g/100g

Purpose: Antiseptic

Purpose

Antiseptic, DISINFECTING WIPES

Use

DISINFECTING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wipe the surface of the skin and let it air dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Phenoxyethanol
Ethylhexyl glycerin
Propylene Glycol
Glycerin
Purified Water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DISINFECTING WIPES 
benzalkonium chloride,didecyl dimethyl ammonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75328-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.2   in 100
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2   in 100

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75328-301-01	1 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75328-301-02	10 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75328-301-03	20 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75328-301-04	30 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75328-301-05	50 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC: 75328-301-06	75 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC: 75328-301-07	80 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
8	NDC: 75328-301-08	100 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
9	NDC: 75328-301-09	120 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
10	NDC: 75328-301-10	160 in 1 BAG; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. (542978427)

Establishment
Name	Address	ID/FEI	Business Operations
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.		542978427	manufacture(75328-301)