Otc - Active Ingredient
Menthol 16%
Rite Aid Hot And Cold Roll On Liquid
FDA Label NDC 11822-1015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Rite Aid Hot And Cold Roll On (NDC 11822-1015). 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 - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Indications & Usage
For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.
Warnings
Flammable--keep away from fire or flame.
For external use only.
When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days, and redness or irritation develops.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Clean affected area before applying product • adults and children 12 years and older, apply to affected area not more
than 3 to 4 times daily. • Children under 12 years old, ask a doctor
Inactive Ingredient
Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum
* Please review the disclaimer below.
