Otc - Active Ingredient
Active Ingredient PurposeMenthol 4%..........................Topical analgesic
Screamin Menthol Toast
FDA Label NDC 52099-8010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Q.a. Laboratories for the product Screamin Menthol Toast (NDC 52099-8010). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses temporarily relieves minor body aches and pains due to: ar thritis pain, back pain, muscle aches,joint pain.
Warnings
Warnings for external use only
Otc - Do Not Use
Do not use immediately before or after bathing or using a hot tub, in conjunction with heating pad,under wrapping or bandage where perspiration is likely to occur.
Otc - Ask Doctor
Stop use and ask doctor if excessive irritation occurs, if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - When Using
When using this product avoid contact with eyes, mucous membranes, open wounds, cuts, abrasions and where skin touches skin, perspiration may increase the sensation of heat, rinse eyes with cold water if irritated.
Otc - Stop Use
Stop use and ask doctor if excessive irritation occurs, if condition worsens ,if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately
Indications & Usage
Directions apply a suitable amount of product to the region of specific pain or injury, avoiding sensitive areas reapply up to three times per daily, wash hands thoroughly in the event of contact. First time users should apply a small amount and increase gradually on reapplications depending on reaction. For use on children under the age of 12 consult a physician Arthritis suf ferers: Apply three times daily for two weeks. Wait twenty minutes before washing arthritic hands. Thereafter use as needed.
Safe Handling Warning
Other information
Store at room temperature
Inactive Ingredient
Inactive ingredients
Boswellia Carterii Resin Extract, Capsicum Annuum Resin, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Isopropyl Alcohol, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Leaf Oil, Propylene Glycol, Triethanolamine, Water (Aqua)
Otc - Questions
Questions or comments:
1-800-4NO-PAIN,
toastproducts.com
MFD FOR: Toast Products
400 Sproul Street,
Pittsburgh, PA 15136
MFG IN USA
Dosage & Administration
apply to the region of specific pain or injury
Package Label.Principal Display Panel
Image Of Label (Screaminmenthol)
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