Cleanse Pure
FDA Label NDC 77031-505

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Frozen Wheels, Llc for the product Cleanse Pure (NDC 77031-505). 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 ingredient, purpose, use[s], warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

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 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.

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

Inactive Ingredients

demineralized water, glycerin, carbomer, aloe vera extract, triethanolamine, disodium EDTA.

Packaging

Image Description (Label)

Image Description (Label)

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