Antibacterial Wipes-Kangbei

(badiful) Antibacterial Wipes by

Drug Labeling and Warnings

(badiful) Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by ZHANGZHOU KANGBEI HYGIENIC PRODUCTS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

(BADIFUL) ANTIBACTERIAL WIPES- benzalkonium chloride swab 
ZHANGZHOU KANGBEI HYGIENIC PRODUCTS CO., LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Antibacterial Wipes-Kangbei

Benzalkonium Chloride
Cetylpridnium Chloride
Propylene Glycol
Chlorphenesin

Purpose: Antiseptic

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.

How to use

Wipe the body skin or other surface
Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Water

Wipe the body skin or other surface
Supervise children under 6 years of age when using this product to avoid swallowing.

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

Antiseptic

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

10pcs/bag NDC: 78453-001-02

100pcs/box NDC: 78453-001-08

(BADIFUL) ANTIBACTERIAL WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78453-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	5 mg  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	2 mg  in 100 mL
CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ)	CHLORPHENESIN	2 mg  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78453-001-01	0.02 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
2	NDC: 78453-001-02	0.2 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
3	NDC: 78453-001-03	0.4 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
4	NDC: 78453-001-04	0.6 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
5	NDC: 78453-001-05	1 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
6	NDC: 78453-001-06	1.14 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
7	NDC: 78453-001-07	1.48 mL in 1 BAG; Type 0: Not a Combination Product	05/31/2020
8	NDC: 78453-001-08	1.9 mL in 1 BOX; Type 0: Not a Combination Product	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/31/2020	11/22/2021

Labeler - ZHANGZHOU KANGBEI HYGIENIC PRODUCTS CO., LTD. (415797593)

Registrant - ZHANGZHOU KANGBEI HYGIENIC PRODUCTS CO., LTD. (415797593)

Establishment
Name	Address	ID/FEI	Business Operations
ZHANGZHOU KANGBEI HYGIENIC PRODUCTS CO., LTD.		415797593	manufacture(78453-001)

Revised: 11/2021

Document Id: d175f4b3-3930-df16-e053-2a95a90a91b9

34390-5

Set id: a72d0e38-b5bd-4726-e053-2a95a90a791c

Version: 2

Effective Time: 20211123

 

ZHANG