Clear Defense
FDA Label NDC 54473-296

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Clear Defense (NDC 54473-296). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient
Ethyl Alcohol 62%

Otc - Purpose

Purpose
Antimicrobial

Indications & Usage

Uses

  • to reduce bacteria on the skin
  • recommended for repeated use

Warnings

Warnings
For External use only
Highly flammable. Keep away from fire or flame.

Otc - Do Not Use

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

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.

Dosage & Administration

Directions

  • dispense a generous amount of gel in your palm
  • spread gel over your hands until thoroughly coated
  • rub your hands together briskly until dry
  • children under 6 should be supervised when using this product

Storage And Handling

Other information

  • store below 82°F (28°C)

Precautions

Other information

  • may discolor certain fabrics or surfaces

Inactive Ingredient

Inactive ingredients
water, glycerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia (tea tree) leaf oil, polysorbate 20, tocopheryl acetate

Package Label.Principal Display Panel

Image Of Label (Cd9gellabel)

Image Of Label (Cd9gellabel)

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