BABY WIPE PREMIUM by SHINWA INTERNATIONAL CORPORATION BABY WIPE PREMIUM

BABY WIPE PREMIUM by

Drug Labeling and Warnings

BABY WIPE PREMIUM by is a Otc medication manufactured, distributed, or labeled by SHINWA INTERNATIONAL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABY WIPE PREMIUM- high quality cotton non-woven fabric cloth 
SHINWA INTERNATIONAL CORPORATION

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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BABY WIPE PREMIUM

BABY WIPE PREMIUM

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.1% w/w, Antiseptic

Purpose

Antiseptic, BABY WIPE PREMIUM

Use

BABY WIPE PREMIUM to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

• 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.

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.

Directions

• Wipe the skin and let it dry naturally.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

PURIFIED WATER
PROPYLEN GLYCOL
DISODIUM COCOAMPHODIACETATE
2-BROMO-2-NITROPROPANE 1.3-DIOL

Package Label - Principal Display Panel

BABY WIPE PREMIUM 
high quality cotton non-woven fabric cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81889-401
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   in 100

Inactive Ingredients
Ingredient Name	Strength
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
BRONOPOL (UNII: 6PU1E16C9W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81889-401-01	50 in 1 BAG; Type 0: Not a Combination Product	05/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/06/2021	05/13/2021

Labeler - SHINWA INTERNATIONAL CORPORATION (673077340)

Establishment
Name	Address	ID/FEI	Business Operations
SHINWA INTERNATIONAL CORPORATION		673077340	manufacture(81889-401)

Revised: 5/2021

Document Id: c2314a86-e4f4-4f70-e053-2a95a90a8418

34390-5

Set id: c207a19c-80b9-62a3-e053-2995a90aa8c0

Version: 2

Effective Time: 20210513