d5021e6d-f29f-446b-874c-bdcabd9cf4f6

SPL v3
SPL
SPL Set ID d5021e6d-f29f-446b-874c-bdcabd9cf4f6
Route
topical
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (10 g) menthol (8 g) camphor (natural) (3 g)
Inactive Ingredients
alcohol arnica montana whole bis-peg-12 dimethicone (70 mpa.s) bis-peg-10 dimethicone/dimer dilinoleate copolymer water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-02-10

Purpose

Topical Analgesic

Description

Camphor 3% Menthol 8% Methyl salicylate 10%


Medication Information

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

Uses

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

Purpose

Topical Analgesic

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.

Other Information

• Store at 59°F - 77°F

Inactive Ingredients

Alcohol Denat., Arnica Montana Flower Extract, Bis-Peg 12 Dimethicone, Bis-Peg 10 Dimethicone, Water

Description

Camphor 3% Menthol 8% Methyl salicylate 10%

Section 50565-1

Drug Facts

Product Label

Active Ingredients

Camphor 3%

Menthol 8%

Methyl salicylate 10%

Questions Or Comments?

Call toll-free 1.888.829.7165


Structured Label Content

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

Uses

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

Purpose

Topical Analgesic

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.

Other Information (Other information)

• Store at 59°F - 77°F

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Arnica Montana Flower Extract, Bis-Peg 12 Dimethicone, Bis-Peg 10 Dimethicone, Water

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredients (Active ingredients)

Camphor 3%

Menthol 8%

Methyl salicylate 10%

Questions Or Comments? (Questions or comments?)

Call toll-free 1.888.829.7165


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)