16.9OZ Hand Sanitizer by MCURE HEALTH SOLUTIONS INC.

16.9OZ Hand Sanitizer by

Drug Labeling and Warnings

16.9OZ Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MCURE HEALTH SOLUTIONS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

16.9OZ HAND SANITIZER- ethyl alcohol gel 
MCURE HEALTH SOLUTIONS INC.

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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Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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 do not use in or near the eyes.

In case of contact, 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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 30°C (86°F)

Inactive ingredients

Glycerin, Water, Carbomer, Fragrance

Package Label - Principal Display Panel

225 ml NDC: 52486-240-03

16.9OZ HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52486-240-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	03/31/2020

Labeler - MCURE HEALTH SOLUTIONS INC. (053034873)

Revised: 4/2020

Document Id: a23f1721-fc4c-eaa3-e053-2995a90ae0da

34390-5

Set id: a230a853-bb6a-213f-e053-2a95a90af5d5

Version: 3

Effective Time: 20200401

 

MCURE HEALTH SOLUTIONS INC.