59088-259-07 Camphor 4% + Menthol 10%

59088-259-07 Camphor 4% + Menthol 10%
SPL v1
SPL
SPL Set ID 3cab26e4-e377-f26a-e063-6394a90a17af
Route
TOPICAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg) Camphor (synthetic) (40 mg)
Inactive Ingredients
Alcohol Ilex Paraguariensis Leaf Indian Frankincense Chondroitin Sulfate (bovine) Magnesium Chloride Mentha Piperita (peppermint) Oil Propylene Glycol Water Glucosamine Sulfate Glycerin Eucalyptus Globulus Leaf Oil Dimethyl Sulfone Triethanolamine Methacrylic Acid - Ethyl Acrylate Copolymer (4500 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-20

Description

Camphor 4% Menthol 10%

Purpose

Analgesic (pain relief)


Medication Information

Purpose

Analgesic (pain relief)

Description

Camphor 4% Menthol 10%

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Warnings

For external use only

Directions
  • adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily.
  • children under the age of 12: do not use, consult a doctor
  • use only as directed
Do Not Use On
  • wounds
  • damaged skin
Other Information
  • keep container tightly closed
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

Camphor 4%

Menthol 10%

Inactive Ingredients

Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Powder, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.

When Using This Product
  • avoid getting into eyes or mucous membranes
  • do not bandage tightly
Camphor 4 % + Menthol 10%

​Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Stop Use and Ask A Doctor If
  • excessive irritation of the skin develops
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

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


Structured Label Content

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Purpose

Analgesic (pain relief)

Warnings

For external use only

Directions
  • adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily.
  • children under the age of 12: do not use, consult a doctor
  • use only as directed
Do Not Use On (Do not use on)
  • wounds
  • damaged skin
Other Information (Other information)
  • keep container tightly closed
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

Camphor 4%

Menthol 10%

Inactive Ingredients (Inactive ingredients)

Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Powder, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.

When Using This Product (When using this product)
  • avoid getting into eyes or mucous membranes
  • do not bandage tightly
Camphor 4 % + Menthol 10%

​Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • excessive irritation of the skin develops
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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.


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Raw Label Data

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