87179-053-02

87179-053-02
SPL v1
SPL
SPL Set ID 42d17270-f58d-9d69-e063-6294a90a4078
Route
TOPICAL
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3 g) Menthol (5 g)
Inactive Ingredients
Dimethyl Sulfone Phenoxyethanol Aloe Vera Leaf Triethanolamine Melaleuca Alternifolia (tea Tree) Leaf Oil Glycerin Dimethicone 1000 Stearyl Alcohol Glyceryl Stearate Alcohol Stearic Acid Panthenol Cetyl Alcohol Ethylhexylglycerin Paraffinum Liquidum Polysorbate 60 Water Trideceth-6 Polysorbate 20 Cetearyl Alcohol Helianthus Annuus (sunflower) Seed Oil Carbomer Homopolymer Type C

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-10

Description

Camphor 3% Menthol 5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 3% Menthol 5%

Use

Aid for temporary local relief of minor pain in muscles or joints.

Warnings

For external use only.

Ask a doctor before use if you have redness over affected area.

Directions

Adults and children over 12 years of age

  • Apply a small amount to the affected area.
  • Massage in a circular motion, let set for a few seconds.
  • Repeat as necessary, but no more than 3 to 4 times daily.
  • Wash hands with soap and water after use.

Children under 12 years of age:do not use unless directed by doctor.

Other Information

Store tightly closed in a dry place at controlled room temperature between 59°F - 86°F (15°C - 30°C)

Active Ingredients

Camphor 3%

Menthol 5%

Inactive Ingredients

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycerin, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Methylsulfonylmethane, Panthenol, Phenoxyethanol, Ethylhexylglycerin.

Core Relief Cream Jar

Questions Or Comments?

(615)908-3117

When Using This Product
  • Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not bandage tightly or use with a heating pad.
  • A transient burning sensation or redness may occur upon application but generally disappears in several days.
  • If you experience an allergic reaction, discontinue use, and consult a physician.
  • Do not apply on large areas of the body or on damaged, broken, or irritated skin.
  • Do not expose the area treated with product to heat or direct sunlight.
Core Relief Cream Sachet

Stop Use and Ask A Doctor If
  • Redness is present.
  • Condition worsens.
  • Irritation develops.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • You experience signs injury, such as pain, swelling or blistering where the product was applied.
Keep Out of Reach of Children.

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

If Pregnant Or Breast – Feeding

Ask a health professional before use.


Structured Label Content

Use

Aid for temporary local relief of minor pain in muscles or joints.

Purpose

Topical Analgesic

Warnings

For external use only.

Ask a doctor before use if you have redness over affected area.

Directions

Adults and children over 12 years of age

  • Apply a small amount to the affected area.
  • Massage in a circular motion, let set for a few seconds.
  • Repeat as necessary, but no more than 3 to 4 times daily.
  • Wash hands with soap and water after use.

Children under 12 years of age:do not use unless directed by doctor.

Other Information (Other information)

Store tightly closed in a dry place at controlled room temperature between 59°F - 86°F (15°C - 30°C)

Active Ingredients (Active ingredients)

Camphor 3%

Menthol 5%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycerin, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Methylsulfonylmethane, Panthenol, Phenoxyethanol, Ethylhexylglycerin.

Core Relief Cream Jar (CORE RELIEF CREAM JAR)

Questions Or Comments? (Questions or comments?)

(615)908-3117

When Using This Product (When using this product)
  • Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not bandage tightly or use with a heating pad.
  • A transient burning sensation or redness may occur upon application but generally disappears in several days.
  • If you experience an allergic reaction, discontinue use, and consult a physician.
  • Do not apply on large areas of the body or on damaged, broken, or irritated skin.
  • Do not expose the area treated with product to heat or direct sunlight.
Core Relief Cream Sachet (CORE RELIEF CREAM SACHET)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Redness is present.
  • Condition worsens.
  • Irritation develops.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • You experience signs injury, such as pain, swelling or blistering where the product was applied.
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.

If Pregnant Or Breast – Feeding (If pregnant or breast – feeding)

Ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)