SPL v3
SPL
SPL Set ID 2eccf23c-fae2-423c-9cae-549bc4194104
Route
TOPICAL
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (11 g) Levomenthol (4 g) Camphor (synthetic)
Inactive Ingredients
Alcohol Arnica Montana Flower Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Ceteth-10 Phosphate Dihexadecyl Phosphate Eucalyptus Oil Cetostearyl Alcohol Cannabis Sativa Seed Oil Ethylhexylglycerin Phenoxyethanol Glycerin Isopropyl Palmitate Dimethyl Sulfone Rice Bran Oil Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Camphor 4% Menthol 4% Methyl salicylate 11%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 4% Menthol 4% Methyl salicylate 11%

Uses

Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Section 50565-1

Warnings

For external use only



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on children 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

  • condition worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children.

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

Directions

Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

Drug Facts

Product Label

Other Information

• Store at 59°F - 77°F

• If seal is broken, do not use

Active Ingredients

Camphor 4%

Menthol 4%

Methyl salicylate 11%

Inactive Ingredients

Alcohol Denat., Arnica Montana Flower Extract, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Eucalyptus Globulus Leaf Oil, Cetearyl Alcohol, Hemp Seed Oil, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane, Oryza Sativa (Rice) Bran Oil, Sodium Hydroxide, Water

Questions Or Comments?

Call toll-free 1.888.829.7165


Structured Label Content

Uses

Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Section 50565-1 (50565-1)

Purpose

Topical Analgesic

Warnings

For external use only



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on children 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

  • condition worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children.

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

Directions

Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and 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

• If seal is broken, do not use

Active Ingredients (Active ingredients)

Camphor 4%

Menthol 4%

Methyl salicylate 11%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Arnica Montana Flower Extract, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Eucalyptus Globulus Leaf Oil, Cetearyl Alcohol, Hemp Seed Oil, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane, Oryza Sativa (Rice) Bran Oil, Sodium Hydroxide, Water

Questions Or Comments? (Questions or comments?)

Call toll-free 1.888.829.7165


Advanced Ingredient Data


Raw Label Data

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