Ambi Soothing Hand Sanitizer Gel
FDA Label NDC 73453-143

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ambi Enterprises, Llc for the product Ambi Soothing Hand Sanitizer (NDC 73453-143). 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:, do not use, when using this product, 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

Ethyl Alcohol 70%

Purpose

Topical Antimicrobial

Uses:

  • 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

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.

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:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aminomethylpropanediol, Aqua (Deionized Water), Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polysorbate-20

Questions?

(800) 946-6354 (M-F) (9-5pm EST)

Package Labeling:

Bottle3 (Bottle3)

Bottle3 (Bottle3)

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