Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 77d43488-16b7-4bd8-8f1d-93789b9fbaa8
Route
TOPICAL
Published
Effective Date 2011-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.6 g) Camphor (synthetic)
Inactive Ingredients
Water Cetyl Alcohol Glycol Stearate Dimethyl Sulfone Glycerin Stearyl Alcohol Glucosamine Sulfate Acrylamide C13-14 Isoparaffin Laureth-7 Alpha-tocopherol Acetate Methyl Salicylate Cucumaria Frondosa Grape Seed Oil Urea Phenoxyethanol Sorbic Acid Polysorbate 20 Eucalyptus Oil Thymol Aloe Vera Leaf Sulfate Ion Magnesium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-06-21

Description

Camphor 4.0% Menthol 4.0%

Purpose

Analgesic (pain relief) Analgesic (pain relief)


Medication Information

Purpose

Analgesic (pain relief)

Analgesic (pain relief)

Description

Camphor 4.0% Menthol 4.0%

Uses:

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

Section 51945-4

Placeholder Text

Warnings:

For external use only.

  • Avoid getting into eyes or on mucous membranes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tightly.

Directions:

Adults and children 12 years of age or older: Rub this soothing cream on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Other Information:

Store under normal storage conditions. Store away from children.

Inactive Ingredients:

Water/Aqua; Cetyl Alcohol, Glycol Stearate, MSM (Methylsulfonylmethane), Glycerin, Stearyl Alcohol, Glucosamine Sulfate, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Tocopheryl (Vitamain E) Acetate, Oil of Wintergreen (Methyl Salicylate), Cucumaria (Sea Cucumber) Frondosa, Grape Seed Oil, Urea, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Polysorbate-20, Eucalyptus Globulus Leaf Oil, Thymol, Aloe Barbadensis Leaf Juice, Chondroitin Sulfate, Magnesium Chloride

Keep Out of Reach of Children.
  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • If swallowed, get medical help or contact a Poison Control center right away

Active Ingredient (% By Weight)
Camphor 4.0%

Menthol 4.0%

Questions?/tiene Alguna Pregunta?

Llame al 416-967-3746


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.

Section 51945-4 (51945-4)

Placeholder Text

Purpose

Analgesic (pain relief)

Analgesic (pain relief)

Warnings:

For external use only.

  • Avoid getting into eyes or on mucous membranes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tightly.

Directions:

Adults and children 12 years of age or older: Rub this soothing cream on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Other Information:

Store under normal storage conditions. Store away from children.

Inactive Ingredients:

Water/Aqua; Cetyl Alcohol, Glycol Stearate, MSM (Methylsulfonylmethane), Glycerin, Stearyl Alcohol, Glucosamine Sulfate, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Tocopheryl (Vitamain E) Acetate, Oil of Wintergreen (Methyl Salicylate), Cucumaria (Sea Cucumber) Frondosa, Grape Seed Oil, Urea, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Polysorbate-20, Eucalyptus Globulus Leaf Oil, Thymol, Aloe Barbadensis Leaf Juice, Chondroitin Sulfate, Magnesium Chloride

Keep Out of Reach of Children. (Keep out of reach of children.)
  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • If swallowed, get medical help or contact a Poison Control center right away

Active Ingredient (% By Weight) (Active Ingredient (% by weight))
Camphor 4.0%

Menthol 4.0%

Questions?/tiene Alguna Pregunta? (Questions?/Tiene alguna pregunta?)

Llame al 416-967-3746


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)