FDA Label for Solmate Burn Relief Gel
View Indications, Usage & Precautions
Solmate Burn Relief Gel Product Label
The following document was submitted to the FDA by the labeler of this product Prime Enterprises, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Principal Display Panel - 591 Ml Bottle Label
SOL
MATE
LOVE THE SUN
BURN RELIEF GEL
External Analgesic
with Lidocaine
Contains
Skin Moisturizing
Aloe Vera
20 FL OZ (591 mL)
Active Ingredients
Lidocaine Hydrochloride 0.72 %
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
Otc - When Using
- 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, discountinue use of this product and consult a physician.
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 afftected area not more than 3 to 4 times daily.
- Children under 2 years of age: ask a doctor.
Inactive Ingredients
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
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