SPL v5
SPL
SPL Set ID e2452c4b-2548-497f-828b-5d960402522a
Route
TOPICAL
Published
Effective Date 2021-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 g) Camphor (synthetic) (10 g) Salicylic Acid (25 g)
Inactive Ingredients
Alcohol Cannabis Sativa Seed Oil Anhydrous Citric Acid Eucalyptus Oil Peppermint Oil Rosemary Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-07

Description

Camphor 10%,  Menthol 8%,  Methyl salicylate 25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 10%,  Menthol 8%,  Methyl salicylate 25%

Uses

Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints 

Warnings



For External Use Only. Flammable. Keep away from heat or flame.

Do not Use

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly 

Stop use and ask a doctor if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days

excessive skin irritation occurs.

Directions

Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and allowed to dry or thoroughly massage until penetrated.  Wash hands with soap and water after use.

Product Label

Other Information

Store at 59°F - 77°F

Active Ingredients

Camphor 10%, 

Menthol 8%, 

Methyl salicylate 25%

Inactive Ingredients

Alcohol Denat., Cannabis Sativa Seed Oil, Citric Acid, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

Questions Or Comments?

Call toll-free 1.888.829.7165

Keep Out of Reach of Children

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


Structured Label Content

Uses

Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints 

Purpose

Topical Analgesic

Warnings



For External Use Only. Flammable. Keep away from heat or flame.

Do not Use

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly 

Stop use and ask a doctor if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days

excessive skin irritation occurs.

Directions

Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and allowed to dry or thoroughly massage until penetrated.  Wash hands with soap and water after use.

Product Label (Product label)

Other Information (Other information)

Store at 59°F - 77°F

Active Ingredients (Active ingredients)

Camphor 10%, 

Menthol 8%, 

Methyl salicylate 25%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Cannabis Sativa Seed Oil, Citric Acid, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

Questions Or Comments? (Questions or comments?)

Call toll-free 1.888.829.7165

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)