Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 013beea4-b2c2-4e84-b4cb-3125ac48e8c0
Route
TOPICAL
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (25 mg)
Inactive Ingredients
Camphor (synthetic) Carbomer Homopolymer Type C Isopropyl Alcohol Methylparaben Polysorbate 60 Potassium Sorbate Trolamine Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01

Description

Menthol 2.5%


Medication Information

Warnings and Precautions

For External Use Only.

Do not use:

On wounds or damaged skin

With a heating pad

On children under 12 years of age with arthritis-like conditions

Ask a doctor before use if:

You have redness over the affected area

When using this product:

Avoid contact eith eyes or mucous membranes

Do not bandage tightly

Stop use and ask a Doctor if:

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

Dosage and Administration

Adults 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor

Description

Menthol 2.5%

Section 50565-1

Keep out of Reach of Children. If swallowed, get medical help of contact a Poison Control Center immediately.

Section 51727-6

Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

Section 51945-4
Section 55105-1

Topical Analegesic

Section 55106-9

Menthol 2.5%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

Dosage and Administration (34068-7)

Adults 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

For External Use Only.

Do not use:

On wounds or damaged skin

With a heating pad

On children under 12 years of age with arthritis-like conditions

Ask a doctor before use if:

You have redness over the affected area

When using this product:

Avoid contact eith eyes or mucous membranes

Do not bandage tightly

Stop use and ask a Doctor if:

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Section 50565-1 (50565-1)

Keep out of Reach of Children. If swallowed, get medical help of contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Topical Analegesic

Section 55106-9 (55106-9)

Menthol 2.5%


Advanced Ingredient Data


Raw Label Data

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