75427-014

75427-014
SPL v4
SPL
SPL Set ID acbddc02-c9ed-f96b-e053-2a95a90ab071
Route
TOPICAL
Published
Effective Date 2020-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-28

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses

For handwashing to decrease bacteria on the skin

Warnings

For external use only.

Do not use in the eyes or apply over large areas of the body.

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

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

Directions

Tear open packet, unfold and use as a washcloth

Do Not Use

Do not use in the eyes or apply over large areas of the body.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store at room temperature:

15°-30℃ (59°-86℉)

Inactive Ingredients

Purified Water

When Using This Product

Do not use in the eyes or apply over large areas of the body.

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

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

Stop Use and Ask A Doctor

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

Keep Out of Reach of Children

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

Package Label Principal Display Panel


Structured Label Content

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antiseptic

Warnings (WARNINGS)

For external use only.

Do not use in the eyes or apply over large areas of the body.

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

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

Directions

Tear open packet, unfold and use as a washcloth

Do Not Use (Do not use)

Do not use in the eyes or apply over large areas of the body.

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.13%

Other Information

Store at room temperature:

15°-30℃ (59°-86℉)

Inactive Ingredients

Purified Water

When Using This Product (When using this product)

Do not use in the eyes or apply over large areas of the body.

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

Keep Out of Reach of Children (Keep out of reach of children)

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

Package Label Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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