75% Alcohol Hand Sanitizing Wipes

75% Alcohol Hand Sanitizing Wipes by

Drug Labeling and Warnings

75% Alcohol Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Shandong BaiHe Sanitary Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

75% ALCOHOL HAND SANITIZING WIPES- alcohol cloth 
Shandong BaiHe Sanitary Products 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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75% Alcohol Hand Sanitizing Wipes

Drug Facts

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses:

Decrease bacteria on the skin that could 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 

on open skin wounds. 

When using this product, 

• keep out of eyes, ears and mouth.
• In case of contact with eyes, rinse thoroughly with water immediately.

Stop using and consult a doctor 

• if irritation or rash occurs, these may be sighs of a serious condition.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center immediately.
• Discard used wipes immediately to prevent cross contamination.
• Children should be under adult supervision when using this product.
• Not recommended for infants.

Directions for use:

• Open the pouch. 
• Pull out wipe and close the pouch.
• Unfold and wipe hands, fingers and wrists thoroughly and allow to dry.
• For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe.
• Discard after single use.
• Make sure to close the pouch firmly after use to retain moisture.

Inactive Ingredients:

Water, Propylene Glycol, Glycerin

Other information:

• Store between 59-86°F (15-30°C).
• Avoid freezing and excessive heat above 104°F (40°C)
• May discolor some fabrics.
• Harmful to wood finishes and plastics.
• Lot number and expiry date can be found on packet.
• Dispose of wipe in proper container after use.
• Do not flush.

Package Labeling:

75% ALCOHOL HAND SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75428-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75428-003-10	100 in 1 PACKAGE	08/22/2020
1		3 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/22/2020

Labeler - Shandong BaiHe Sanitary Products Co., Ltd (549556417)

Revised: 9/2020

Document Id: ae7cc723-7728-8d55-e053-2995a90aff56

34390-5

Set id: ae7cc723-7727-8d55-e053-2995a90aff56

Version: 1

Effective Time: 20200904

 

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