Solmate
FDA Label NDC 58443-0145

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 Solmate (NDC 58443-0145). 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 principal display panel - 591 ml  bottle label, active ingredients, purpose, uses, warnings, otc - when using, 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

Principal Display Panel - 591 Ml  Bottle Label

Principal Display Panel (591 mL Bottle Label)

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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