Disinfectant wet wipe

Active Ingredient(s)

Benzalkonium chloride 0.8mg/mL
Cetylpyridinium Chloride 0.5mg/mL
Didecyldimonium Chloride 0.32mg/mL

Purpose: Antiseptic

Purpose

Antiseptic

Use

Disinfectant wet wipe 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 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 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.

Directions

Wipe the body skin or other surface
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

Glycerin
Aloe Barbadensis Leaf Extract
Chamomilla Recutita Flower Extract
Decyl glucoside
Aqua

Package Label - Principal Display Panel

Label 120

DISINFECTANT WET WIPE
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75111-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 mg in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.8 mg in 1 mL
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.32 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75111-301-01	48 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC:75111-301-02	182 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC:75111-301-03	216 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC:75111-301-04	302 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2020

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

Labeler - Enping Jiaxin Daily Necessities Co., Ltd. (403010421)

Name	Address	ID/FEI	Business Operations
Establishment
Enping Jiaxin Daily Necessities Co., Ltd.		403010421	manufacture(75111-301)