Otc - Active Ingredient
Menthol 0.5%
Pr Lotion
FDA Label NDC 72358-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amphp, Inc for the product Pr (NDC 72358-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain relieving sports lotion
Indications & Usage
For the temporary relief of pain
Warnings
For external use only
Otc - Do Not Use
Do not use if allergic to any ingredient in this product or sensitive to sodium
Otc - When Using
Use only as directed. Avoid contact with eyes.
Otc - Stop Use
Stop use and ask doctor if:
Symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant of breast-feeding, ask a health professional before use
Otc - 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.
Dosage & Administration
Shake well. 15 miutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands.
Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: consult a doctor
Other Safety Information
Store at 20-25C (68-77F)
Inactive Ingredient
sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance
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