Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 77ab634e-13d4-4f5f-87c8-73976e65a842

Route

TOPICAL

Published

Effective Date 2019-04-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzocaine (200 mg) Menthol, Unspecified Form (10 mg)

Inactive Ingredients

Fd&c Blue No. 1 Isopropyl Alcohol Peg-8 Laurate Water

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-02-15 Until 2017-03-15

Description

Benzocaine USP 20% Menthol USP 1%

Purpose

(for pain) Topical Anesthetic (anti-itch) Antipruritic

Medication Information

Purpose

(for pain) Topical Anesthetic

(anti-itch) Antipruritic

Description

Benzocaine USP 20% Menthol USP 1%

Uses

▪
Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.

Warnings

▪
For external use only
▪
Do not apply over large areas of the body
▪
Avoid contact with eyes, mouth, and mucous membranes

Directions

Children under 2 yrs.

▪
Do not use
▪
Consult doctor

Adults and children 2 yrs. and older

▪
Clean area
▪
Apply to affected area as needed not more than 3 to 4 times a day.

Active Ingredient

Benzocaine USP 20%

Menthol USP 1%

Inactive Ingredients

FD&C Blue #1, Isopropyl Alcohol 15%, PEG-8 Laurate, Water.

Keep Out of Reach of Children

If swallowed get medical help or contact Poison Control Center right away.

Package/label Principal Display Panel

NEW!

KILLS THE PAIN

STOPS THE ITCH

FIRE OUT™

INSTANT PAIN RELIEF

from:

Fire Ant Stings

also from:

Mosquito Bites Insect Bites
Jellyfish Stings Bee Stings

MAXIMUM STRENGTH

PAIN RELIEVING LIQUID

NO-MESS ROLL-ON

1.7 fl oz (50 ml)

MADE IN THE USA

DUAL ACTION

Structured Label Content

Uses

▪
Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.

Purpose

(for pain) Topical Anesthetic

(anti-itch) Antipruritic

Warnings

▪
For external use only
▪
Do not apply over large areas of the body
▪
Avoid contact with eyes, mouth, and mucous membranes

Directions

Children under 2 yrs.

▪
Do not use
▪
Consult doctor

Adults and children 2 yrs. and older

▪
Clean area
▪
Apply to affected area as needed not more than 3 to 4 times a day.

Active Ingredient (Active ingredient)

Benzocaine USP 20%

Menthol USP 1%

Inactive Ingredients

FD&C Blue #1, Isopropyl Alcohol 15%, PEG-8 Laurate, Water.

Keep Out of Reach of Children

If swallowed get medical help or contact Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NEW!

KILLS THE PAIN

STOPS THE ITCH

FIRE OUT™

INSTANT PAIN RELIEF

from:

Fire Ant Stings

also from:

Mosquito Bites Insect Bites
Jellyfish Stings Bee Stings

MAXIMUM STRENGTH

PAIN RELIEVING LIQUID

NO-MESS ROLL-ON

1.7 fl oz (50 ml)

MADE IN THE USA

DUAL ACTION

Advanced Ingredient Data

[{"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-8 LAURATE", "unii": "762O8IWA10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "▪ Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.", "Purpose": "(for pain) Topical Anesthetic (anti-itch) Antipruritic", "Warnings": "▪ For external use only ▪ Do not apply over large areas of the body ▪ Avoid contact with eyes, mouth, and mucous membranes", "Directions": "Children under 2 yrs. ▪ Do not use ▪ Consult doctor Adults and children 2 yrs. and older ▪ Clean area ▪ Apply to affected area as needed not more than 3 to 4 times a day.", "Active ingredient": "Benzocaine USP 20% Menthol USP 1%", "Inactive Ingredients": "FD&C Blue #1, Isopropyl Alcohol 15%, PEG-8 Laurate, Water.", "Keep Out of Reach of Children": "If swallowed get medical help or contact Poison Control Center right away.", "Package/Label Principal Display Panel": "NEW! KILLS THE PAIN STOPS THE ITCH FIRE OUT™ INSTANT PAIN RELIEF from: Fire Ant Stings also from: Mosquito Bites Insect Bites Jellyfish Stings Bee Stings MAXIMUM STRENGTH PAIN RELIEVING LIQUID NO-MESS ROLL-ON 1.7 fl oz (50 ml) MADE IN THE USA DUAL ACTION"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:47.763409 · Updated: 2026-03-14T22:55:31.631898