Active Ingredients Purpose
Lidocaine HCL 4%............................Topical analgesic
Menthol 1%.....................................Topical analgesic
Maximum Strength Cold And Hot
FDA Label NDC 69842-667
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Maximum Strength Cold And Hot (NDC 69842-667). 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 purpose, uses, warningsfor external use only, when using this product, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves pain and itching due to:
• sunburn • minor burns • minor cuts • scrapes • insect bites
Warningsfor External Use Only
Do not use • in large quantities, particularly over raw surface or blistered areas
When Using This Product
•avoid contact with eyes
• do not apply to wounds or damages skin
• do not bandage tightly or use with a heating pad
• use only as directed
Directions
• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Aloe Barbadensis Leaf Extract
Aminomethyl Propanol
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer
Caprylyl Methicone
Cetearyl Alcohol
Ceteth-20 Phosphate
Dicetyl Phosphate
Dimethicone
Disodium EDTA
Ethylhexylglycerin
Glyceryl Stearate SE
Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer
Isohexadecane
Methylparaben
Polysorbate 60
SD Alcohol 40
Steareth-21
Water
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