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SPL v1

SPL

SPL Set ID b4b22554-b35e-4f9d-a8d0-d7293e50725a

Route

TOPICAL

Published

Effective Date 2021-07-06

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 NOT FINAL Active Since 2022-03-14

Description

DRUG FACTS

Purpose

Topical Anesthetic And Antiseptic

Medication Information

Warnings and Precautions

Warnings

Purpose

Topical Anesthetic And Antiseptic

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

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.

Structured Label Content

Uses:

Stops itching and pain associated with insect bites or stings.

Warnings and Precautions (34071-1)

Warnings

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)

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. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"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"}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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: 2026-02-15T12:00:08.951948 · Updated: 2026-03-14T23:00:30.367061