Gaffer And Child Hand Sanitizer
FDA Label NDC 80634-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gaffer And Child, Llc for the product Gaffer And Child Hand Sanitizer (NDC 80634-002). 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 drug facts, active ingredients, purpose, use(s), warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Use(S)

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 fire 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

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

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 at 15°-30°C (59°-86°F)
  • Avoid freezing / excessive heat above 40C (104F)

Inactive Ingredients

golden lemon essential oil, vegetable glycerin, purified water

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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