Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4869ad5b-4f43-4f88-aa96-0c966d538347
Route
TOPICAL
Published
Effective Date 2020-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (4.9 mg)
Inactive Ingredients
Water Aloe Vera Leaf Polysorbate 20 Glycerin Potassium Sorbate Citric Acid Monohydrate Edetate Disodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01

Description

Benzalkonium Chloride 0.12%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.12%

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.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

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

Section 50567-7

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

Section 50570-1

Do not use in the eyes.

Warnings

For external use only.

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

Benzalkonium Chloride 0.12%

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


Structured Label Content

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.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use in the eyes.

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Wet hands thoroughly with product and allow to dry.
  • Children under six years of age should be supervised when using this product.
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.12%

Other Information (Other information)
  • Store in a cool, dry place.
Inactive Ingredients (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


Advanced Ingredient Data


Raw Label Data

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