Happy Hands
FDA Label NDC 80849-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Ethanol Company, Llc for the product Happy Hands (NDC 80849-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl Alcohol 80% v/v.

Purpose

Antimicrobial

Use

For daily hand sanitizing when soap and water are not an option. Apply to hands, then rub thoroughly over all surfaces to kill most germs, bacteria, and viruses.

Warnings


For external use only. Do not inhale or ingest. Keep out of eyes.

Flammable, keep away from fire, sparks, and sources of ignition. Do not store above 104°F/40°C.

When using this product Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Stop use and ask Doctor if irritation and redness develop and persist for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
  • Not recommended for infants.

Inactive Ingredients

Glycerin (moisturizer), Hydrogen Peroxide, and Purified Water.

Package Label - Principal Display Panel

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