drug facts

Composition & Product

Active Ingredients

menthol (16 g) salicylic acid (32 g)

Inactive Ingredients

petrolatum

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2024-10-19 Until 2029-11-22

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredients

Menthol 16%

Methyl salicylate 32%

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints due to

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration

Directions

Adults and children 3 years of age and older: Apply a small amount with your finger tip then gently rub into the affected area not more than 3 to 4 times daily.

Children under 3 years of age: Do not use, consult your doctor.

Description

Active ingredients Menthol 16% Methyl salicylate 32%

Section 44425-7

Other information

keep container tightly closed

store at 15° to 30°C (59° to 86°F)

Section 50565-1

Keep out of reach of children to avoid accidental poisoning

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

Section 50566-9

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive irritation of the skin develops

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

when using for pain of arthritis

pain persists for more than 10 days

redness is present

in conditions affecting children under 12 years of age

Section 50567-7

When using this product

avoid contact with the eyes or mucous membranes

do not bandage tightly

Section 50570-1

Do not use

on wounds

on irritated or damaged skin

on the face

otherwise than as directed

Section 51727-6

Inactive ingredients

Petrolatum

Section 51945-4

ELECTRIC MEDICATED BALM

External Analgesic

NDC 63299-001-01

NET 2.45 oz (70g)

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

External analgesic

External analgesic

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredients

Menthol 16%

Methyl salicylate 32%

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints due to

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration (34068-7)

Directions

Adults and children 3 years of age and older: Apply a small amount with your finger tip then gently rub into the affected area not more than 3 to 4 times daily.

Children under 3 years of age: Do not use, consult your doctor.

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store at 15° to 30°C (59° to 86°F)

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive irritation of the skin develops

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

when using for pain of arthritis

pain persists for more than 10 days

redness is present

in conditions affecting children under 12 years of age

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes or mucous membranes

do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds

on irritated or damaged skin

on the face

otherwise than as directed

Section 51727-6 (51727-6)

Inactive ingredients

Petrolatum

Section 51945-4 (51945-4)

ELECTRIC MEDICATED BALM

External Analgesic

NDC 63299-001-01

NET 2.45 oz (70g)

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External analgesic

External analgesic

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "16", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "32", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of minor aches and pains of muscles and joints due to simple backache arthritis strains bruises sprains", "34068-7": "Directions Adults and children 3 years of age and older: Apply a small amount with your finger tip then gently rub into the affected area not more than 3 to 4 times daily. Children under 3 years of age: Do not use, consult your doctor.", "34071-1": "Warnings For external use only", "44425-7": "Other information keep container tightly closed store at 15° to 30°C (59° to 86°F)", "50565-1": "Keep out of reach of children to avoid accidental poisoning If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs when using for pain of arthritis pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age", "50567-7": "When using this product avoid contact with the eyes or mucous membranes do not bandage tightly", "50570-1": "Do not use on wounds on irritated or damaged skin on the face otherwise than as directed", "51727-6": "Inactive ingredients Petrolatum", "51945-4": "ELECTRIC MEDICATED BALM External Analgesic NDC 63299-001-01 NET 2.45 oz (70g)", "53413-1": "Questions or comments? (888) 221-3496 M-F 9am to 5pm you may also report serious side effects to this phone number", "55105-1": "Purpose External analgesic External analgesic", "55106-9": "Active ingredients Menthol 16% Methyl salicylate 32%"}