Otc - Active Ingredient
Menthol 10.5%
Dzul Pain Freeze Spray
FDA Label NDC 83037-510
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caball Sales, Inc. for the product Dzul Pain Freeze (NDC 83037-510). 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, use, warnings, flammable, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Use
For temporary relief of minor aches and pains of muscles and joints.
Warnings
For external use only.
Do not apply to wounds or damaged skin, with a heating pad or on a child under 12 years of age.
Flammable
Keep away from fire or flame.
Otc - When Using
Use only as directed.
Do not bandage tightly.
Avoid contact with eyes and mucous membranes.
If you experience an allergic reaction, discontinue use, and consult a doctor.
Do not expose the area treated with product to heat or direct sunlight.
Stop Use And Ask A Doctor If
Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.
You experience signs of injury, such as pain, swelling or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast – feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison Control Center right away.
Directions
Adults and Children over 12 years of age
Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.
Children under 12 years of age: do not use, consult a doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).
Inactive Ingredient
Alcohol Denat, Glycerin, Propylene Glycol, Aloe Barbadensis (Aloe Vera) Leaf Juice.
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