81635-001

81635-001
SPL v1
SPL
SPL Set ID f821e791-7eb1-4b21-9364-05ca89f3e7c1
Route
TOPICAL
Published
Effective Date 2021-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Propylene Glycol Polysorbate 20 Water Phenoxyethanol Aloe Vera Leaf .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-12

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Use

■ To decrease bacteria on the skin that could cause disease

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 or rash occurs. These may be signs of a serious condition

Section 51945-4

Warnings

For external use only

Do not use

In children less than two monthsof age.

On open skin wounds

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Directions

Open package, pull wipe. Close package to retain moisture. Wet hands thoroughly with product. Allow to dry without rinsing

Supervise children under six years of age when using this product to avoid swallowing

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Keep container tightly closed in a dry, cool, and well ventilated place.

Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive Ingredients

Alow Barbadensis leaf jiuce, Phenoxyethanol, Polysorbate 20, Propylene glycol, Tocopheryl Acetate, Water


Structured Label Content

Use

■ To decrease bacteria on the skin that could cause disease

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 or rash occurs. These may be signs of a serious condition

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings (WARNINGS)

For external use only

Do not use

In children less than two monthsof age.

On open skin wounds

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Directions

Open package, pull wipe. Close package to retain moisture. Wet hands thoroughly with product. Allow to dry without rinsing

Supervise children under six years of age when using this product to avoid swallowing

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Keep container tightly closed in a dry, cool, and well ventilated place.

Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive Ingredients (Inactive ingredients)

Alow Barbadensis leaf jiuce, Phenoxyethanol, Polysorbate 20, Propylene glycol, Tocopheryl Acetate, Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)