Natural Concepts Alcohol-free Hand Sanitizer
FDA Label NDC 63148-512

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apollo Health And Beauty Care Inc. for the product Natural Concepts Alcohol-free Hand Sanitizer (NDC 63148-512). 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, uses, warnings, when using this product, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only.

When Using This Product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do Not Use

  • on children less than 2 months of age
  • on open skin wounds

Stop Use And Ask A Doctor If

irritation develops.

Keep Out Of Reach Of Children.

If swallowed, call or contact a Poison Control Center or get medical help right away.

Directions

  • put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.

Inactive Ingredients

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

Questions?

1-866-695-3030

Label Copy

Image Of The Label (24828)

Image Of The Label (24828)

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