Active Ingredients
Lidocaine Hydrochloride (0.72%)
Suntone
FDA Label NDC 58443-0125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises Inc. for the product Suntone (NDC 58443-0125). 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, warnings, other, otc - do not use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
Warnings
For external use only.
Other
Avoid contact with the eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and contact a physician.
Otc - Do Not Use
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away..
Directions
- Adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: Ask a doctor
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5
Questions Or Comments?
Biocycle Laboratories, Inc.
16363 NW 49 Avenue, Miami, FL 33014
Suntone After Sun Burn Relief With Lidocaine
Principal Display Image (58443 0125 6)
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