Active And Innovative (as Pld) - Musclecare Ointment (70039-303)

Active And Innovative (as Pld) - Musclecare Ointment (70039-303)
SPL v3
SPL
SPL Set ID 17961a84-6bee-c75f-e063-6394a90af576
Route
TOPICAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4 g) Menthol
Inactive Ingredients
Acacia Aloe Vera Leaf Carthamus Tinctorius (safflower) Oleosomes Cetostearyl Alcohol Cetyl Alcohol Chondroitin Sulfate (bovine) Glucosamine Sulfate Potassium Chloride Dimethyl Sulfone Ethylhexylglycerin Eucalyptus Oil Methyl Salicylate Glycerin Magnesium Chloride Phenoxyethanol Polysorbate 60 Thymol Tocopherol Urea Grape Seed Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-03

Description

Camphor 4.0% Menthol 4.0%

Purpose

Analgesic (pain relief)


Medication Information

Purpose

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, sprains, bruises.

Section 51945-4

Warnings:

For external use only.

  • Caution: Discontinue use if excessive irritation of the skin develops. 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:

Acacia Senegal Gum, Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetyl Alcohol, Chondroitin Sulfate, D-Glucosamine Sulfate Potassium, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Eucalyptus Globulus Leaf/Twig Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Magnesium Chloride, Phenoxyethanol, Polysorbate 60, Thymol, Tocopherol, Urea, Vitis Vinifera (Grape) Seed Oil, Water, Xanthan Gum

Active Ingredient (% By Weight)

Camphor 4.0%

Menthol 4.0%

Keep Out of Reach of Children. Flammable: Keep Away From Fire and Flame.
  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • 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, sprains, bruises.

Section 51945-4 (51945-4)

Purpose

Analgesic (pain relief)

Warnings:

For external use only.

  • Caution: Discontinue use if excessive irritation of the skin develops. 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:

Acacia Senegal Gum, Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetyl Alcohol, Chondroitin Sulfate, D-Glucosamine Sulfate Potassium, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Eucalyptus Globulus Leaf/Twig Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Magnesium Chloride, Phenoxyethanol, Polysorbate 60, Thymol, Tocopherol, Urea, Vitis Vinifera (Grape) Seed Oil, Water, Xanthan Gum

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

Camphor 4.0%

Menthol 4.0%

Keep Out of Reach of Children. Flammable: Keep Away From Fire and Flame. (Keep out of reach of children. Flammable: Keep away from fire and flame.)
  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • If swallowed, get medical help or contact a Poison Control center right away

Advanced Ingredient Data


Raw Label Data

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