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Calypxo Pain Relief Cream
FDA Label NDC 80425-0369
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Calypxo Pain Relief (NDC 80425-0369). 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 other, active ingredients, purpose, uses, warning, otc - keep out of reach of children, directions, additional information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Methyl Salicylate………10.00%
Menthol…………………3.00%
Purpose
Topical Analgesic
Topical Analgesic
Uses
For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.
Warning
For external use only.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or cover treated areas.
Do not use with heating pad.
Do not apply to open wounds or damages skin.
A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.
If symptoms persist for more than seven days, discontinue use and consult physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, consult physician.
If pregnant or breast feeding, contact physician prior to use.
Directions
For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.
Additional Information
Store at room temperature.
Other Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.
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