1301 Cleansing Towelettes Ndc 67777-243-01

1301 Cleansing Towelettes Ndc 67777-243-01
SPL v31
SPL
SPL Set ID 87288939-cc34-4437-94ab-dcb997d6acd5
Route
TOPICAL
Published
Effective Date 2022-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Methylchloroisothiazolinone/methylisothiazolinone Mixture Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-04-05

Description

Benzalkonium Chloride 0.13% v/v

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Benzalkonium Chloride 0.13% v/v

Uses

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

• Cleans and refreshes hand, face, and body without soap and water.

Label

1301 Cleansing Towelettes

Warnings

For external use only

Direction

• 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-Dynarex Monday - Friday, 9AM - 5PM EST

Active Ingredient

Benzalkonium Chloride 0.13% v/v

Other Information

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

• Avoid excessive heat.

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

Inactive Ingredients

Isopropyl Alcohol, Water, may contain Methylchloroisothiazolinone/Methylisothiazolinone

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 gets 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

Uses

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

• Cleans and refreshes hand, face, and body without soap and water.

Label

1301 Cleansing Towelettes

Purpose

First Aid Antiseptic

Warnings

For external use only

Direction

• 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-Dynarex Monday - Friday, 9AM - 5PM EST

Active Ingredient

Benzalkonium Chloride 0.13% v/v

Other Information

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

• Avoid excessive heat.

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

Inactive Ingredients (Inactive ingredients)

Isopropyl Alcohol, Water, may contain Methylchloroisothiazolinone/Methylisothiazolinone

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 gets 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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