36c11178-b70f-4355-8823-c2b72598dae5

SPL v3

SPL

SPL Set ID 36c11178-b70f-4355-8823-c2b72598dae5

Route

topical

Published

Effective Date 2024-08-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzocaine (6 g) isopropyl alcohol (60 g)

Inactive Ingredients

water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-08-09

Purpose

Topical Anesthetic And Antiseptic

Description

DRUG FACTS

Medication Information

Warnings and Precautions

Warnings

Purpose

Topical Anesthetic And Antiseptic

Directions

Adults and children 2 years of age or older . Cnsult physician for chldren under 2 years old.

Do not apply more than 3 or 4 times daily.

Wipe affected area to alleviate pain and itching.

Discard after use.

Description

DRUG FACTS

Uses:

Stops itching and pain associated with insect bites or stings.

Section 42229-5

DRUG FACTS

Section 50570-1

For external use only.

Flammable .Keep away from fire or flame.

Do not use in the eyes. If irritation or redness occurs, stop use.

Direct contact with open wound will cause stinging.

Section 51945-4

Active Ingredient

Benzocaine ..........................6%

Isopropyl Alcohol ................60%

Inactive Ingredients:

Purified Water.

Keep Out of Reach of Children.

If swallowed get medical help or contact a Posion Control Center immediately.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Purpose

Topical Anesthetic And Antiseptic

Directions

Adults and children 2 years of age or older . Cnsult physician for chldren under 2 years old.

Do not apply more than 3 or 4 times daily.

Wipe affected area to alleviate pain and itching.

Discard after use.

Uses:

Stops itching and pain associated with insect bites or stings.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use only.

Flammable .Keep away from fire or flame.

Do not use in the eyes. If irritation or redness occurs, stop use.

Direct contact with open wound will cause stinging.

Section 51945-4 (51945-4)

Active Ingredient

Benzocaine ..........................6%

Isopropyl Alcohol ................60%

Inactive Ingredients:

Purified Water.

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

If swallowed get medical help or contact a Posion Control Center immediately.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Stops itching and pain associated with insect bites or stings.", "34071-1": "Warnings", "42229-5": "DRUG FACTS", "50570-1": "For external use only. Flammable .Keep away from fire or flame. Do not use in the eyes. If irritation or redness occurs, stop use. Direct contact with open wound will cause stinging.", "Purpose": "Topical Anesthetic And Antiseptic", "Directions": "Adults and children 2 years of age or older . Cnsult physician for chldren under 2 years old. Do not apply more than 3 or 4 times daily. Wipe affected area to alleviate pain and itching. Discard after use.", "Active Ingredient": "Benzocaine ..........................6% Isopropyl Alcohol ................60%", "Inactive Ingredients:": "Purified Water.", "Keep out of reach of children.": "If swallowed get medical help or contact a Posion Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:24.135850 · Updated: 2026-03-14T23:03:28.306097