kinetic ice muscle and joint pain relief cream

kinetic ice muscle and joint pain relief cream
SPL v2
SPL
SPL Set ID 565f0e20-e534-41db-ba20-e726d578405f
Route
topical
Published
Effective Date 2020-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (100 mg)
Inactive Ingredients
aloe vera leaf water arnica montana flower indian frankincense carbomer homopolymer, unspecified type ethylhexylglycerin glyceryl monostearate magnesium sulfate, unspecified form melaleuca alternifolia leaf dimethyl sulfone polysorbate 20 phenoxyethanol pyridoxine hydrochloride alcohol stearic acid trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-11-10

Purpose

Topical Analgeic

Description

Menthol 10%


Medication Information

Purpose

Topical Analgeic

Description

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.

Warnings:

For external use only.

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age: consult a doctor. 
Do Not Use:

on damaged or broken skin.

Drug Facts:

Phone Number:

+1(413) 422-3267

Package Labeling:

Other Information:

Protect the product in this container from excessive heat and direct sun.

Active Ingredients:

Menthol 10%

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glyceryl Stearate, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Polysorbate-20, Phenoxyethanol, Pyridoxine HCL (Vitamin B6), SD-Alcohol 40B, Stearic Acid, Triethanolamine.

When Using This Product:

Avoid contact with the eyes. Do not bandage tightly.

Stop Use and Ask A Doctor If:
  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for 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

Purpose

Topical Analgeic

Uses:

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

Warnings:

For external use only.

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age: consult a doctor. 
Do Not Use: (Do not use:)

on damaged or broken skin.

Drug Facts:

Phone Number: (Phone number:)

+1(413) 422-3267

Package Labeling:

Other Information: (Other information:)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients:

Menthol 10%

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glyceryl Stearate, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Polysorbate-20, Phenoxyethanol, Pyridoxine HCL (Vitamin B6), SD-Alcohol 40B, Stearic Acid, Triethanolamine.

When Using This Product:

Avoid contact with the eyes. Do not bandage tightly.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for 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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