Active Ingredient
Menthol USP 4% Active
X-treme Freeze Gel
FDA Label NDC 67777-144
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product X-treme Freeze (NDC 67777-144). 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 ingredient, purpose, use, warnings, flammable:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cooling Pain Relief
Use
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains, sprains.
Warnings
For external use only
Flammable:
Keep away from excessive heat or open flame
Ask A Doctor Before Use If You Have:
sensitive skin
When Using This Product:
- Avoid contact with eyes or mucous membranes
- Do not apply to wounds or damaged skin
- Do not use with other ointments, creams, sprays or liniments
- Do not apply to irritated skin or if excessive irritation develops
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device
Stop Use And Ask A Doctor If:
- condition worsens
- symptoms last 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
If swallowed, get medical help, contact a physician or Poison Control Center right away.
Directions
- Adults and children 2 years of age or older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
- Children under 2 years of age: Consult physician
Other Information
Store in a cool dry place
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine
Questions?
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