ANTIBACTERIAL WET WIPES- 0.13% benzalkonium chloride cloth

Antibacterial Wet Wipes by

Drug Labeling and Warnings

Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by Kunming Ansheng Industry & Trade Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.13% v/v;

Purpose

Antibacterial; Kill 99% of germs that may cause illness in just 5 minutes;

Use

For hand washing to decrease bacteria on the skin.
Recommended for repeated use.
Do not push fingers through opening.

Warnings

For external use only. Read the product label carefully before use.

Do not use

• on infants less than 2 months of age
• on open skin wounds
• If you have hypersensitivity to any of the components of the formula, do not use the product.

WHEN USING

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse immediately with plenty of water for several minuter;

In case of ingestion, do not induce vomiting and consult a doctor immediately, taking the product container or label.

STOP USE

Stop usage if skin irritation occurs and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets.

Directions

Directions (For bag package)

After use, dispose the wipes in the trash. Do not flush in toilet.
Always reseal the transparent seal securely between the uses to

Directions (For Canister package)

Remove the wipe from the center of the canister.

The next wipe will come out automatically.

Close the lid to keep the wipes moist.

Other information

• Keep containers tightly closed in a cool, dry place and well-ventilated place.
• Recommended Store temperature: 0℃ to 40℃
• Keep wipes inside the original packaging.
• Store unopened packages in a cool, dry place away from direct light inaccessible to small children.

Inactive ingredients

Aqua, Ethanol, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20, Phenoxyethanol, Parfum

Package Label - Principal Display Panel

80 wipes in 1 bag; NDC: 78183-006-01;

80 wipes in 1 canister；NDC: 78183-006-02；

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WET WIPES 
0.13% benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78183-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 U  in 100 U

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)	10 U  in 100 U
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.05 U  in 100 U
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.1 U  in 100 U
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 U  in 100 U
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.05 U  in 100 U

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78183-006-01	80 U in 1 BAG; Type 0: Not a Combination Product	07/13/2020
2	NDC: 78183-006-02	80 U in 1 CANISTER; Type 0: Not a Combination Product	07/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/02/2020

Labeler - Kunming Ansheng Industry & Trade Co., Ltd. (421081801)

Establishment
Name	Address	ID/FEI	Business Operations
Kunming Ansheng Industry & Trade Co., Ltd.		421081801	manufacture(78183-006) , label(78183-006)