dr. paine's pain relief cream

dr. paine's pain relief cream
SPL v2
SPL
SPL Set ID 79d2b332-051e-48c1-afe8-6d4468cd1878
Route
topical
Published
Effective Date 2020-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (50 mg)
Inactive Ingredients
gluconolactone glycerin glyceryl monostearate helianthus annuus flowering top magnesium sulfate, unspecified form dimethyl sulfone sodium benzoate sorbitan olivate stearic acid xanthan gum corn propanediol aloe vera leaf water arnica montana flower indian frankincense bromelains cetearyl olivate cetyl alcohol eucalyptus oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-06-20

Description

Menthol 5.00%


Medication Information

Warnings

For external use only.

Avoid contact with eyes. 

If symptoms persist for more than seven days,discontinue use and consult physician.

Directions

Apply to affected area not more than three to four times daily. Adults and children two-years of age or older:

consult a physician. Children under two-years of age:

Description

Menthol 5.00%

Section 55105-1

Topical Analgesic

Do Not 

apply to wounds damaged skin.

Do not bandage tightly.

Indications

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

Package Labeling:

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Cetearyl Olivate, Cetyl Alcohol, Eucalyptus Globulus Oil, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Active Ingredients:

Menthol 5.00%

Additional Information

store at room temperature.

Questions Or Comments?

Call toll free 1-855-537-7246 (1-855-5DRPAIN)

Keep Out of Reach of Children.

If swallowed, consult physician.

If Pregnant Or Breast Feeding, 

contact physician prior to use.


Structured Label Content

Warnings

For external use only.

Avoid contact with eyes. 

If symptoms persist for more than seven days,discontinue use and consult physician.

Directions

Apply to affected area not more than three to four times daily. Adults and children two-years of age or older:

consult a physician. Children under two-years of age:

Section 55105-1 (55105-1)

Topical Analgesic

Do Not  (Do not )

apply to wounds damaged skin.

Do not bandage tightly.

Indications

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

Package Labeling:

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Cetearyl Olivate, Cetyl Alcohol, Eucalyptus Globulus Oil, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Active Ingredients:

Menthol 5.00%

Additional Information (Additional information)

store at room temperature.

Questions Or Comments? (Questions or comments?)

Call toll free 1-855-537-7246 (1-855-5DRPAIN)

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, consult physician.

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

contact physician prior to use.


Advanced Ingredient Data


Raw Label Data

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