hand sanitizer -61305 ISOPROPYL RUBBING ALCOHOL

ISOPROPYL RUBBING ALCOHOL by

Drug Labeling and Warnings

ISOPROPYL RUBBING ALCOHOL by is a Otc medication manufactured, distributed, or labeled by Zhejiang Meizhiyuan Cosmetics Co., Ltd, Townley Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISOPROPYL RUBBING ALCOHOL 01- alcohol gel 
Zhejiang Meizhiyuan Cosmetics 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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hand sanitizer -61305
ISOPROPYL RUBBING ALCOHOL

Drug facts

Active Ingredient( by volume) Purpose

Isopropyl Alcohol (99% conc.) ....First aid Antiseptic

Uses

First aid to help prevent the risk of infection in minor cuts, scrapes and burns.

Warnings for external use only.

Flammable, Keep away from heat and flame, heat spark or electricity.

If taken internally, serious gastric disturbances will result.

Ask a doctor before use if you have deep or puncture wounds, animals bites, or serious burns.

WHEN USING THIS PRODUCT

Do not get in eyes

Do not apply over large areas of the body

Do not use longer than one week unless directed by a doctor.

Stop use and ask a doctor if conditions persist or gets worse.

Keep out of reach of children.

In case of ingestion, get medical help or contact a poison control center right away.

Directions:

Clean the affected area

Apply small amount of this product on the area 1-3 times daily

Let the alcohol dry on skin before using bandages.

May be covered with a sterile bandage.

Other information

Store at room temperature

Does not contain, nor is intended as a substitute for grain or ethyl alcohol.

Inactive Ingredients:

Water( aqua)

ISOPROPYL RUBBING ALCOHOL  01
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54304-077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	99 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	1 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54304-077-01	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/25/2020	07/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/25/2020	07/14/2020

Labeler - Zhejiang Meizhiyuan Cosmetics Co., Ltd (543036597)

Revised: 7/2020

Document Id: aa77d38c-6e10-b928-e053-2a95a90afdb4

34390-5

Set id: a98515bc-fa98-3eb6-e053-2995a90aa547

Version: 3

Effective Time: 20200715