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SPL v13

SPL

SPL Set ID 70df2ef5-44d3-446f-98d0-557b5f2bdd2b

Route

topical

Published

Effective Date 2024-06-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzocaine (5 mg) phenol (1.35 mg) camphor (natural) (3 mg)

Inactive Ingredients

propylene glycol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2013-11-01

Description

Drug Facts

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

First aid to help prevent infection in minor cuts, scrapes, and burns. For temporary relief of pain and itching associated with:

insect bites
minor burns
minor cuts
skin rashes due to poison ivy, poison oak, and poison sumac.

Dosage and Administration

Clean the affected area. Apply a small amount of this product on the affected area while massaging with sponge tip applicator. If itching persists, apply again in 10-15 minutes.
For ticks and bees, remove tick or stinger before treatment.
Adults and children 2 years of age and older: Apply to affected area not more than 1-3 times daily. Children under 2 years of age: Consult a doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. If in eyes, flush with water for 15 minutes and call a physician.

Section 50566-9

Stop use and ask doctor if conditions worsen, or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use longer than one week unless directed by a doctor.

Section 50567-7

Do not get in eyes
Do not apply over large areas of the body
In case of deep or puncture wounds, animal bites, or serious burns consult a doctor.
Do not bandage.

Section 51727-6

Propylene Glycol

Section 51945-4

SCJohnson

A Family Company

Forgot

Your OFF!^®

Repellent?

Get Quick

Relief from

Bites & Itching.

OFF!^®

familycare

BITE AND ITCH RELIEF

FIRST AID

ANTISEPTIC

TOUCH FREE NO MESS

APPLICATION

SOOTHES BITES FROM

MOSQUITOES AND

OTHER INSECTS

RELIEVES ITCH FROM

POISON IVY,

POISON OAK, AND

POISON SUMAC

ANTISEPTIC

RELIEVES ITCH

SPONGE TIP

APPLICATOR

NET 0.5 FL. OZ. (15 mL)

Section 53413-1

1-800-294-3632

Section 55105-1

Active Ingredients	Purpose
Benzocaine 5%	Analgesic, Anesthetic, Antipruritic
Camphor 3%	Topical Analgesic
Phenol 1.35%	First Aid Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Indications and Usage (34067-9)

First aid to help prevent infection in minor cuts, scrapes, and burns. For temporary relief of pain and itching associated with:

insect bites
minor burns
minor cuts
skin rashes due to poison ivy, poison oak, and poison sumac.

Dosage and Administration (34068-7)

Clean the affected area. Apply a small amount of this product on the affected area while massaging with sponge tip applicator. If itching persists, apply again in 10-15 minutes.
For ticks and bees, remove tick or stinger before treatment.
Adults and children 2 years of age and older: Apply to affected area not more than 1-3 times daily. Children under 2 years of age: Consult a doctor.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. If in eyes, flush with water for 15 minutes and call a physician.

Section 50566-9 (50566-9)

Stop use and ask doctor if conditions worsen, or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use longer than one week unless directed by a doctor.

Section 50567-7 (50567-7)

Do not get in eyes
Do not apply over large areas of the body
In case of deep or puncture wounds, animal bites, or serious burns consult a doctor.
Do not bandage.

Section 51727-6 (51727-6)

Propylene Glycol

Section 51945-4 (51945-4)

SCJohnson

A Family Company

Forgot

Your OFF!^®

Repellent?

Get Quick

Relief from

Bites & Itching.

OFF!^®

familycare

BITE AND ITCH RELIEF

FIRST AID

ANTISEPTIC

TOUCH FREE NO MESS

APPLICATION

SOOTHES BITES FROM

MOSQUITOES AND

OTHER INSECTS

RELIEVES ITCH FROM

POISON IVY,

POISON OAK, AND

POISON SUMAC

ANTISEPTIC

RELIEVES ITCH

SPONGE TIP

APPLICATOR

NET 0.5 FL. OZ. (15 mL)

Section 53413-1 (53413-1)

1-800-294-3632

Section 55105-1 (55105-1)

Active Ingredients	Purpose
Benzocaine 5%	Analgesic, Anesthetic, Antipruritic
Camphor 3%	Topical Analgesic
Phenol 1.35%	First Aid Antiseptic

Advanced Ingredient Data

[{"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "ACTIB", "strengthNumerator": "1.35", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "First aid to help prevent infection in minor cuts, scrapes, and burns. For temporary relief of pain and itching associated with: insect bites minor burns minor cuts skin rashes due to poison ivy, poison oak, and poison sumac.", "34068-7": "Clean the affected area. Apply a small amount of this product on the affected area while massaging with sponge tip applicator. If itching persists, apply again in 10-15 minutes. For ticks and bees, remove tick or stinger before treatment. Adults and children 2 years of age and older: Apply to affected area not more than 1-3 times daily. Children under 2 years of age: Consult a doctor.", "34071-1": "For external use only.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. If in eyes, flush with water for 15 minutes and call a physician.", "50566-9": "Stop use and ask doctor if conditions worsen, or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use longer than one week unless directed by a doctor.", "50567-7": "Do not get in eyes Do not apply over large areas of the body In case of deep or puncture wounds, animal bites, or serious burns consult a doctor. Do not bandage.", "51727-6": "Propylene Glycol", "51945-4": "SCJohnson A Family Company Forgot Your OFF! ® Repellent? Get Quick Relief from Bites & Itching. OFF! ® familycare BITE AND ITCH RELIEF FIRST AID ANTISEPTIC TOUCH FREE NO MESS APPLICATION SOOTHES BITES FROM MOSQUITOES AND OTHER INSECTS RELIEVES ITCH FROM POISON IVY, POISON OAK, AND POISON SUMAC ANTISEPTIC RELIEVES ITCH SPONGE TIP APPLICATOR NET 0.5 FL. OZ. (15 mL)", "53413-1": "1-800-294-3632", "55105-1": "Active Ingredients Purpose Benzocaine 5% Analgesic, Anesthetic, Antipruritic Camphor 3% Topical Analgesic Phenol 1.35% First Aid Antiseptic"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:09.495980 · Updated: 2026-03-06T01:19:25.445898