SPL v3
SPL
SPL Set ID 48fd73e7-1443-4ac7-bf7c-d99bf2449f51
Route
TOPICAL
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (25 g) Menthol (16 g) Camphor (natural) (11 g)
Inactive Ingredients
Anhydrous Citric Acid Cannabis Sativa Seed Oil Eucalyptus Oil Peppermint Oil Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-16

Description

Camphor 11% Menthol 16% Methyl salicylate 25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 11% Menthol 16% Methyl salicylate 25%

Uses

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

Section 50565-1

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 and/or excessive skin irritation occurs.



Keep out of reach of children

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

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.

Drug Facts

Product Label

Other Information

• Store at 59°F - 77°F

Active Ingredients

Camphor 11%

Menthol 16%

Methyl salicylate 25%

Inactive Ingredients

Alcohol Denat., Cannabis Sativa Seed Oil, Citric Acid, Mentha Piperita (Peppermint) Oil

Questions Or Comments?

Call toll-free 1.888.829.7165


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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 and/or excessive skin irritation occurs.



Keep out of reach of children

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

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.

Drug Facts

Product Label (Product label)

Other Information (Other information)

• Store at 59°F - 77°F

Active Ingredients (Active ingredients)

Camphor 11%

Menthol 16%

Methyl salicylate 25%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Cannabis Sativa Seed Oil, Citric Acid, Mentha Piperita (Peppermint) Oil

Questions Or Comments? (Questions or comments?)

Call toll-free 1.888.829.7165


Advanced Ingredient Data


Raw Label Data

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