SPL v1
SPL
SPL Set ID a6de38b6-3cd4-482a-ba78-30d01250a595
Route
TOPICAL
Published
Effective Date 2018-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (100 mg) Menthol
Inactive Ingredients
Clove Oil Cottonseed Oil Cetostearyl Alcohol Eucalyptus Oil Hemp Jojoba Oil Peppermint Oil Water Shea Butter Sorbic Acid Stearic Acid Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-03

Description

Active Ingredients: Camphor 10%, Menthol 10% (External Analgesics)

Purpose

Active Ingredients: Camphor 10%, Menthol 10% (External Analgesics)


Medication Information

Indications and Usage

Purpose

Active Ingredients: Camphor 10%, Menthol 10% (External Analgesics)

Description

Active Ingredients: Camphor 10%, Menthol 10% (External Analgesics)

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

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 cream into affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Inactive Ingredients

Clove oil, cotton seed oil, emulsifying wax, eucalyptus oil, hemp extrct*, jojoba seed oil, peppermint oil, purified water, shea butter, sorbic acid,

stearic acid, tea tree oil.

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

Active Ingredients: Camphor 10%, Menthol 10% (External Analgesics)


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Indications and Usage (34067-9)

Warnings

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 cream into affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Inactive Ingredients (Inactive ingredients)

Clove oil, cotton seed oil, emulsifying wax, eucalyptus oil, hemp extrct*, jojoba seed oil, peppermint oil, purified water, shea butter, sorbic acid,

stearic acid, tea tree oil.

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

Active Ingredients: Camphor 10%, Menthol 10% (External Analgesics)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)