Fl-2011

Fl-2011
SPL v3
SPL
SPL Set ID 0e1f3653-d75e-9c9e-e063-6294a90ab639
Route
TOPICAL
Published
Effective Date 2024-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-08

Description

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Benzalkonium Chloride 0.13%

Label

FL-2011

Use(s)

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

Warnings

For External Use Only

Directions

• Clean the affected area.

• May be covered with a sterile bandage.

• If bandaged, let dry first.

Do Not Use

• As an antiseptic for more than 1 week

• In the eyes

Questions?

1-888-900-2920 Monday-Friday, 8AM-4PM PST

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

• Store at room temperature 15º-30ºC (59º-86°F).

• Avoid excessive heat.

•Tamper Evident. Do not use if packet is torn or cut.

Inactive Ingredients

Water

Ask A Doctor Before Use If

you have deep or puncture wounds, animal bites, or serious burns.

Stop Use and Ask A Doctor If

• Irritation and redness develop

• Condition persists or get worse

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Label

FL-2011

Use(s)

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

Purpose

First Aid Antiseptic

Warnings

For External Use Only

Directions

• Clean the affected area.

• May be covered with a sterile bandage.

• If bandaged, let dry first.

Do Not Use (Do not use)

• As an antiseptic for more than 1 week

• In the eyes

Questions?

1-888-900-2920 Monday-Friday, 8AM-4PM PST

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)

• Store at room temperature 15º-30ºC (59º-86°F).

• Avoid excessive heat.

•Tamper Evident. Do not use if packet is torn or cut.

Inactive Ingredients (Inactive ingredients)

Water

Ask A Doctor Before Use If (Ask a doctor before use if)

you have deep or puncture wounds, animal bites, or serious burns.

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

• Irritation and redness develop

• Condition persists or get worse

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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