SPL v1
SPL
SPL Set ID 76678d20-24a4-4c8b-8855-76b30e560d90
Route
TOPICAL
Published
Effective Date 2019-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (100 mg) Menthol
Inactive Ingredients
White Wax Clove Oil Cottonseed Oil Eucalyptus Oil Frankincense Oil Hemp Jojoba Oil Lavender Oil Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-06

Description

Camphor 10%, Menthol 10% (External Analgesics)

Purpose

Camphor 10%, Menthol 10% (External Analgesics)


Medication Information

Indications and Usage

Purpose

Camphor 10%, Menthol 10% (External Analgesics)

Description

Camphor 10%, Menthol 10% (External Analgesics)

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis.

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: • avoid contact with eyes or mucous membranes • do not bandage tightly or use with a heating pad. 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 develops.

Directions

Adults and children 12 years of age and older: massage ointment into affected area not more than 3 to 4 times daily. Wash hands with soap and water after use. Children under 12 years of age: ask a doctor.

Inactive Ingredients

Beeswax (organic), clove oil, cotton seed oil, eucalyptus oil, frankincense oil, hemp extract (THC-free), jojoba seed oil, lavender oil, sorbic acid

Principal Display Panel

Keep Out of Reach of Children

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

Active Ingredients and Purpose

Camphor 10%, Menthol 10% (External Analgesics)


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis.

Indications and Usage (34067-9)

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: • avoid contact with eyes or mucous membranes • do not bandage tightly or use with a heating pad. 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 develops.

Directions

Adults and children 12 years of age and older: massage ointment into affected area not more than 3 to 4 times daily. Wash hands with soap and water after use. Children under 12 years of age: ask a doctor.

Inactive Ingredients (Inactive ingredients)

Beeswax (organic), clove oil, cotton seed oil, eucalyptus oil, frankincense oil, hemp extract (THC-free), jojoba seed oil, lavender oil, sorbic acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep out of reach of children)

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

Active Ingredients and Purpose

Camphor 10%, Menthol 10% (External Analgesics)


Advanced Ingredient Data


Raw Label Data

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