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

Purpose

Topical Analgesic

Description

Benzocaine, 6% w/v


Medication Information

Warnings

For External Use Only

Flammable. Keep away from fire or flame.

Purpose

Topical Analgesic

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.

Other Information

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

• Avoid excessive heat

Inactive Ingredients

Water

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

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

Active Ingredients

Benzocaine, 6% w/v

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

Warnings

For External Use Only

Flammable. Keep away from fire or flame.

Purpose

Topical Analgesic

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.

Other Information (Other information)

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

• Avoid excessive heat

Inactive Ingredients

Water

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

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

Active Ingredients (Active ingredients)

Benzocaine, 6% w/v

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

All Sections (JSON)