SPL v2
SPL
SPL Set ID ae71a05b-8ec8-bf9f-e053-2995a90a5a4c
Route
TOPICAL
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Sodium Bicarbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-04

Description

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic.


Medication Information

Purpose

First Aid Antiseptic.

Dosage and Administration

Apply a small amount of this product on the area 1 to 3 times daily.

Description

Benzalkonium Chloride 0.13%

Use

First aid antiseptic to help prevent infection in minor cuts,scrapes and burns.

Warnings

For external use only.

Do not use

In the eyes or apply over large areas of the body.

In case of deep or puncture wounds,animal bites or serious burns,consult a doctor.

Stop use

If the condition persists or gets worse,consult a doctor.

Do not use longer than 1 week unless directed by a doctor.

Directions

Clean the affected area.

Apply a small amount of this product on the area 1 to 3 times daily.

May be covered with a sterile bandage.

If bandaged,let dry first.

Other Information

Store at room temperature:15-30℃(59-86℉)

Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredient

Purified water, sodium bicarbonate.

Keep Out of Reach of Children

Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.

Label Principal Display Panel


Structured Label Content

Use (USE)

First aid antiseptic to help prevent infection in minor cuts,scrapes and burns.

Dosage and Administration (34068-7)

Apply a small amount of this product on the area 1 to 3 times daily.

Purpose

First Aid Antiseptic.

Warnings (WARNINGS)

For external use only.

Do not use

In the eyes or apply over large areas of the body.

In case of deep or puncture wounds,animal bites or serious burns,consult a doctor.

Stop use

If the condition persists or gets worse,consult a doctor.

Do not use longer than 1 week unless directed by a doctor.

Directions (DIRECTIONS)

Clean the affected area.

Apply a small amount of this product on the area 1 to 3 times daily.

May be covered with a sterile bandage.

If bandaged,let dry first.

Other Information

Store at room temperature:15-30℃(59-86℉)

Active Ingredients (ACTIVE INGREDIENTS)

Benzalkonium Chloride 0.13%

Inactive Ingredient (INACTIVE INGREDIENT)

Purified water, sodium bicarbonate.

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

Keep out of reach of children. if swallowed get medical help or contact Poison control Center right away.

Label Principal Display Panel (Label principal display panel)


Advanced Ingredient Data


Raw Label Data

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