PREMIUM ALCOHOL WIPES by SHINWA INTERNATIONAL CORPORATION PREMIUM ALCOHOL WIPES

PREMIUM ALCOHOL WIPES by

Drug Labeling and Warnings

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

Drug Details [pdf]

PREMIUM ALCOHOL WIPES- high quality cotton non-woven fabric cloth 
SHINWA INTERNATIONAL CORPORATION

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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PREMIUM ALCOHOL WIPES

PREMIUM ALCOHOL WIPES

Active Ingredient(s)

Alcohol 1mL/Cloth. Purpose: Antiseptic

Purpose

Antiseptic, PREMIUM ALCOHOL WIPES

Use

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

Warnings

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

Do not use

• 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.

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

WATER
GLYCERIN
MOISTURIZER (ALOE)
PROPYLEN GLYCOL
DISODIUM COCOAMPHODIACETATE
2-BROMO-2-NITROPROPANE 1.3-DIOL
PEG 40 HYDROGENATED CASTOR OIL
FRAGRANCE, 4-ISOPROPYL-3-METHYLPHENOL

Package Label - Principal Display Panel

PREMIUM ALCOHOL WIPES 
high quality cotton non-woven fabric cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81889-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
BRONOPOL (UNII: 6PU1E16C9W)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81889-101-01	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
OTC monograph not final	part333A	05/06/2021	05/11/2021

Labeler - SHINWA INTERNATIONAL CORPORATION (673077340)

Establishment
Name	Address	ID/FEI	Business Operations
SHINWA INTERNATIONAL CORPORATION		673077340	manufacture(81889-101)

Revised: 5/2021

Document Id: c207d3a2-0baf-a9ce-e053-2a95a90ac836

34390-5

Set id: c1aaeeb1-28ef-c5c5-e053-2995a90a082b

Version: 2

Effective Time: 20210511