OTC Medication Information: MyHealth Advanced Hand Sanitizer

MYHEALTH ADVANCED HAND SANITIZER- alcohol liquid
Aeroflex Industria de Aerosol Ltda

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.

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

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.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

aqua, glycerin, butane, propylene glycol, peg-10, parfum, cocoamidepropyl betaine,isobutane, propane, chlorhexidine digluconate, denatonium benzoate, butylphenyl,methylpropional, linalool.

Product label

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MYHEALTH ADVANCED HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80661-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
BUTANE
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL, UNSPECIFIED
SULFURYL FLUORIDE
COCAMIDOPROPYL BETAINE
ISOBUTANE
PROPANE
CHLORHEXIDINE GLUCONATE
DENATONIUM BENZOATE
BUTYLPHENYL METHYLPROPIONAL
LINALOOL, (+/-)-
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80661-002-01 150 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/26/2020
Labeler — Aeroflex Industria de Aerosol Ltda (898397347)
Establishment
Name Address ID/FEI Operations
Aeroflex Industria de Aerosol Ltda 898397347 manufacture (80661-002)

Revised: 11/2021 Aeroflex Industria de Aerosol Ltda

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.

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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