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Solmate Burn Relief Gel

Medically reviewed on January 29, 2018

Dosage form: gel
Ingredients: LIDOCAINE 0.057mg in 1mL
Labeler: Prime Enterprises, Inc.
NDC Code: 58443-0145

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

For external use only

  • 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.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

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 

SOLMATE  BURN RELIEF GEL
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0145
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE0.057 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BENZOPHENONE 
FD&C BLUE NO. 1 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
DMDM HYDANTOIN 
MENTHOL 
METHYLPARABEN 
POLYSORBATE 20 
PROPYLENE GLYCOL 
ALCOHOL 
TROLAMINE 
WATER 
FD&C YELLOW NO. 5 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58443-0145-7591 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2015
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIOperations
Prime Enterprises, Inc.101946028label(58443-0145), pack(58443-0145), manufacture(58443-0145), analysis(58443-0145)

 
Prime Enterprises, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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