ANTI-BACTERIAL WET WIPES-KANGBEI

(sani-maxx) Anti-bacterial Wet Wipes by

Drug Labeling and Warnings

(sani-maxx) Anti-bacterial Wet 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]

(SANI-MAXX) ANTI-BACTERIAL WET 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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ANTI-BACTERIAL WET WIPES-KANGBEI

Benzalkonium Chloride 0.13%

Purpose: Antiseptic/Hand & Skin Sanitizer

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(Aqua), Glycerol, Propanediol, Aloe Vera Extract, Amino acid moisturizer, Hexadecylpyridinium Chloride, Chlorphenesin, Vitamin E, Dodecyl polyglucoside, Citric acid, Sodium citrate.

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/ Hand&Skin Sanitizer

Do not Freeze. For external use only. Store at room temperature..

Do not use in ears,eyes or mouth.

• Avoid contact with the eyes. In case of contact,flush eyes with water.
• Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
• keep out of reach of children.
• Children should be supervised when using this product.
• If swallowed,get medical help or contact poison control centre immediately.

70pcs/bag NDC: 78453-002-01

(SANI-MAXX) ANTI-BACTERIAL WET WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78453-002
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 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
AMINO ACIDS (UNII: 0O72R8RF8A)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
1-HEXADECYL-5-ETHYL-2-METHYLPYRIDINIUM BROMIDE (UNII: W85B4O1R37)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78453-002-01	0.72 mg in 1 BOX; Type 0: Not a Combination Product	09/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/08/2020	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(78453-002)

Revised: 11/2021

Document Id: d175f13b-85cf-1041-e053-2995a90aade0

34390-5

Set id: aecce17b-bb5e-3b35-e053-2995a90a770f

Version: 2

Effective Time: 20211123

 

ZHANG