Otc - Active Ingredient
Menthol 16%
Hot/cold Menthol 16% Roll-on Liquid
FDA Label NDC 82645-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Hot/cold Menthol 16% Roll-on (NDC 82645-014). 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, stop use and ask a doctor if, if pregnant or breast-feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.
Warnings
For external use only.
Flammable
- Keep away from fire or flame.
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- a temporary burning sensation may occur after use but normally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- if swelling or blistering of the skin occurs, stop use and seek medical attention
- do not expose treated area to heat or direct sunlight
When using this product
Stop Use And Ask A Doctor If
- condition worsens
- redness is present
- irritation develops
- 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.
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
Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily
IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.
Children 12 years or younger: do not use, ask a doctor
Inactive Ingredient
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine.
Otc - Questions
1-833-551-0932
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