78028-005 WIPES 0.13% BENZALKONIUM CHLORIDE

WIPES by

Drug Labeling and Warnings

WIPES by is a Otc medication manufactured, distributed, or labeled by Dalian Daxin Nonwoven Technology Co., Ltd., Dalian Daxin Nonwoven Technology Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WIPES- benzalkonium chloride cloth 
Dalian Daxin Nonwoven Technology Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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78028-005 WIPES 0.13% BENZALKONIUM CHLORIDE

Active Ingredient

Purpose

Antibacterial

USE

For sanitizing and to help reduce bacteria on the skin.

Warning

For external use only.

Do not use if you are allergic to any of the ingredients.

If swallowed,get medical help or contact a poison control center right away.

Keep out of reach of children.

Directions

Open the lid and tear off the inner seal.

Gently pull out the wipe.Thoroughly wipe skin as desired.

Dispose the used wipe in trash,do not flush it into the toilet.

Inactive ingredients

Water, Phenoxyethanol, Sodium
benzoate, Propylene glycol, Aloe barbadensis leaf juice, PEG-8
dimethicone, Disodium edta, Citric acid.

WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78028-005
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78028-005-01	20 in 1 BAG	10/30/2020
1		4 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 78028-005-02	30 in 1 BAG	10/30/2020
2		4 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 78028-005-03	50 in 1 BAG	10/30/2020
3		4 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 78028-005-04	80 in 1 BAG	10/30/2020
4		4 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 78028-005-05	100 in 1 BAG	10/30/2020
5		4 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 78028-005-06	76 in 1 PAIL	10/30/2020
6		4 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 78028-005-07	80 in 1 PAIL	10/30/2020
7		4 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 78028-005-08	100 in 1 PAIL	10/30/2020
8		4 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 78028-005-09	160 in 1 PAIL	10/30/2020
9		4 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 78028-005-10	200 in 1 PAIL	10/30/2020
10		4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/30/2020

Labeler - Dalian Daxin Nonwoven Technology Co., Ltd. (415363991)

Establishment
Name	Address	ID/FEI	Business Operations
Dalian Daxin Nonwoven Technology Co., Ltd.		415363991	manufacture(78028-005)

Revised: 11/2022

Document Id: ee09f180-98bb-f94f-e053-2995a90ac9b3

34390-5

Set id: b304180b-16df-72ef-e053-2a95a90aad59

Version: 2

Effective Time: 20221122

 

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