Playmakar Roll On Cool Pain Relief Gel
FDA Label NDC 72909-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Playmakar Inc. for the product Playmakar Roll On Cool Pain Relief (NDC 72909-015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, indications:, warnings, keep out of reach of children, do not apply, if pregnant or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 6%
Indications:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.
Warnings
For external use only
- Avoid contact with eyes
- If symptoms persist for more than seven days, discontinue use and consult physician.
Keep Out Of Reach Of Children
If swallowed, consult physician
Do Not Apply
- to wounds or damaged skin
- Do not bandage tightly
If Pregnant Or Breast Feeding
contact physician prior to use
Directions
- Adults and children two-years of age or older: Apply to affected area not more than three to four times dail
- Children under two-years of age: consult a physician
Other Information
store at room temperature
Inactive Ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20, Tocopheryl Acetate (Vitamin E), Triethanolamine
Package Labeling:
Label3 (Label3)
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