Active Ingredients
Active Ingredients
Menthol 3%
Methyl Salicylate 15%
Hot Stuff
FDA Label NDC 52564-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mueller Sports Medicine for the product Hot Stuff (NDC 52564-108). 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 active ingredients, pupose, uses, warnings, when using this product, stop use and ask a doctor, if pregnant or breast-feeding, 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
Pupose
Purpose
Topical Analgesic
Topical Analgesic
Uses
Temporarily relieves pain from
- sore muscles
- minor aches
- sprains
- strains
- bruises
Warnings
For external use only
Allergy alert: If prone to allergic reaction from menthol, aspirin or salicylates, consult a doctor before use.
When Using This Product
- use only as directed
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with a heating pad
- do not use immediately after a shower or bath
Stop Use And Ask A Doctor
Stop use and ask a doctor if condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- skin redness is present
- excessive skin irritation occurs
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before using
Keep Out Of Reach Of Children
Keep out of children
- if swallowed, get medical help or contact a Poison Control center right away
Directions
Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: ask a doctor
Inactive Ingredients
Cetyl Alcohol, Cetyl Palmitate, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Polysorbate 80, Propylene Glycol, Propyl Paraben, Water
Questions Or Comments?
Call 1-800-356-9522 or
Email us at [email protected]
Other Safety Information
STORE AT NORMAL ROOM TEMPERATURE
Package Label.Principal Display Panel
Label (Hot Stuff Lbl39400 Gs)
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