OTC Medication Information: 7.6OZ Hand Sanitizer

7.6OZ HAND SANITIZER- 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.

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: 52486-260-03

225
(click image for full-size original)

7.6OZ HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52486-260
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYPOLYMETHYLENE
GLYCERIN 1.45 mL in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52486-260-03 225 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — MCURE HEALTH SOLUTIONS INC. (053034873)

Revised: 04/2020 MCURE HEALTH SOLUTIONS INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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