Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0
Route
TOPICAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g) Camphor (synthetic) (5 g) Salicylic Acid (15 g)
Inactive Ingredients
Eucalyptus Oil Lavender Oil Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-01-12 Until 2029-01-29

Description

Active ingredients Menthol 16% Camphor 5% Methyl salicylate 15%


Medication Information

Warnings and Precautions

Warnings

For external use only

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 few drops 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.

Refer to the above warnings; use otherwise than as directed may be dangerous

Description

Active ingredients Menthol 16% Camphor 5% Methyl salicylate 15%

Section 44425-7

Other information

keep container tightly closed

store at 15 to 30C (59 to 86F)

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

Eucalyptus oil, lavender oil and mineral oil.

Section 51945-4

AXE BRAND MEDICATED OIL NDC-57538-003-1 1.89 fl oz (56mL)

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 55106-9

Active ingredients

Menthol 16%

Camphor 5%

Methyl salicylate 15%


Structured Label Content

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 few drops 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.

Refer to the above warnings; use otherwise than as directed may be dangerous

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store at 15 to 30C (59 to 86F)

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

Eucalyptus oil, lavender oil and mineral oil.

Section 51945-4 (51945-4)

AXE BRAND MEDICATED OIL NDC-57538-003-1 1.89 fl oz (56mL)

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 55106-9 (55106-9)

Active ingredients

Menthol 16%

Camphor 5%

Methyl salicylate 15%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)