SUNTONE AFTER SUN BURN RELIEF GEL WITH LIDOCAINE- lidocaine hydrochloride gel 
Prime Enterprises Inc.

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.

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Suntone After Sun Burn Relief Gel with Lidocaine

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.

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, discontinue use of this product and contact 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

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

SUNTONE  AFTER SUN BURN RELIEF GEL WITH LIDOCAINE
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0125-6470 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/07/2011
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0125) , manufacture(58443-0125) , label(58443-0125)

Revised: 6/2020
Document Id: a7945b56-5d0f-2ea7-e053-2995a90a6b08
Set id: 2bea8016-ad69-661d-e054-00144ff88e88
Version: 3
Effective Time: 20200608
 
Prime Enterprises Inc.