Ps-2204

Ps-2204
SPL v3
SPL
SPL Set ID 0e20252a-5ecb-2526-e063-6294a90a8cde
Route
TOPICAL
Published
Effective Date 2024-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (60 mg) Benzocaine (6 mg)
Inactive Ingredients
Water

Identifiers & Packaging

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

Description

Benzocaine, 6% w/v

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Benzocaine, 6% w/v

Label

Use(s)

For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

Warnings

For External Use Only

Flammable. Keep away from fire or flame.

Directions

• For adults and children 2 years of age and older, apply to affected area not more than 3-4 times daily.

• For children under 2 years of age, consult a doctor before use.

Do Not Use

• With electrocautery procedures

When Using

• Avoid contact with eyes; if this occurs, rinse thoroughtly with water

Stop Use If

• Irritation and redness develop

• Condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few day; discontinue use and consult a doctor

Active Ingredient

Isopropyl Alcohol, 60% w/v

Other Information

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

• Avoid excessive heat

Active Ingredients

Benzocaine, 6% w/v

Inactive Ingredients

Water

Questions and Comments?

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

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

Use(s)

For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

Purpose

Topical Analgesic

Warnings

For External Use Only

Flammable. Keep away from fire or flame.

Directions

• For adults and children 2 years of age and older, apply to affected area not more than 3-4 times daily.

• For children under 2 years of age, consult a doctor before use.

Do Not Use (Do not use)

• With electrocautery procedures

When Using (When using)

• Avoid contact with eyes; if this occurs, rinse thoroughtly with water

Stop Use If (Stop use if)

• Irritation and redness develop

• Condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few day; discontinue use and consult a doctor

Active Ingredient

Isopropyl Alcohol, 60% w/v

Other Information (Other information)

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

• Avoid excessive heat

Active Ingredients (Active ingredients)

Benzocaine, 6% w/v

Inactive Ingredients

Water

Questions and Comments?

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

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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