Antiseptic Wipes by Ni Hau Industrial Co., Ltd / Ni Hau Industrial Co., Ltd. NiHau 009-01

Antiseptic Wipes by

Drug Labeling and Warnings

Antiseptic Wipes by is a Otc medication manufactured, distributed, or labeled by Ni Hau Industrial Co., Ltd, Ni Hau Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC WIPES- benzakonium chloride cloth 
Ni Hau Industrial 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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NiHau 009-01

Active Ingredient(s)

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

For hand sanitizing to reduce bacteria on the skin. May be used on face, arms and legs.

Warnings

For external use only. Flammable.

Keep out of eyes. In case of eye contact flush with water.

Stop use and ask a doctor if irritation or rash develops, discontinue use. Consult doctor if irritation persists for more than 72 hours.

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center

Directions

Open resealable label.

Pull one sheet from the pack.

Clean hands or affected area and discard.

Re-seal label after each use to keep wipes fresh.

.

Inactive ingredients

Pure water, Sodium Benzoate, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Citric Acid

Package Label - Principal Display Panel

10 Wipes NDC: 77189-009-01

ANTISEPTIC WIPES 
benzakonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77189-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100

Inactive Ingredients
Ingredient Name	Strength
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77189-009-01	10 in 1 PACKET; Type 0: Not a Combination Product	07/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/21/2020	12/01/2022

Labeler - Ni Hau Industrial Co., Ltd (658274464)

Establishment
Name	Address	ID/FEI	Business Operations
Ni Hau Industrial Co., Ltd.		658274464	manufacture(77189-009)

Revised: 12/2022

Document Id: f12662cc-510c-0536-e053-2a95a90a8459

34390-5

Set id: aafd8748-606a-189f-e053-2995a90af0e1

Version: 4

Effective Time: 20221231