Biocleanze
FDA Label NDC 80537-907

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medredi Llc for the product Biocleanze (NDC 80537-907). 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, otc - do not use, otc - when using, otc - stop use, otc - 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 0.12%

Purpose

Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin.
  • After changing diapers.
  • After assisting ill person s.
  • Before contact with a person under medical care or treatment.
  • Recommended for repeat use.

Warnings

For external use only.

Otc - Do Not Use

Do not use in the eyes.

Otc - When Using

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop.

If condition persists for more than 72 hours consult a doctor.

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.

Directions

  • Wet hands thoroughly with product and allow to dry.
  • Children under six years of age should be supervised when using this product.

Other Information

  • Store in a cool, dry place.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

Principal Display Panel – Canister Label

biocleanze™

ALCOHOL-FREE HAND
SANITIZING WIPES

Kills 99.99% of Germs

  • MOISTURIZES WITH ALOE &
    VITAMINE E
  • LEAVES HANDS FEELING CLEAN

    • BOARD CERTIFIED

    DERMATOLOGIST
    TESTED & APPROVED

    as a non-sensitizer
    or irritant to skin

    CAUTION

    May irritate eyes. See side panel for
    further precautions and first aid instructions

    KEEP OUT OF REACH OF CHILDREN

    NET CONTENTS: 70

    7” x 8” Pre-measured Wipes

    Manufactured For: biocleanze™

    N58 W24668 Clover Drive

    Sussex, WI 53089 | (262) 932-4062

    Principal Display Panel – Canister Label (Bio0c 0000 01)

    Principal Display Panel – Canister Label (Bio0c 0000 01)

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