MIAMI BEACH BURN RELIEF- lidocaine hydrochloride gel 
Miami Beach Brands Corporation

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Miami Beach Burn Relief

​Drug Facts

Active Ingredients

Lidocaine HCL  1.00%

Purpose

Topical Pain Reliever

Indications:

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, cuts and scrapes

Warnings:

  • For external use only

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

  • If symptoms persist for more than seven days, discontinue use and consult physician.
  • ​Avoid contact with eyes.  ​Rinse well if contact occurs.

Keep out of reach of children.

If swallowed, consult physician.

Directions:

  • Adults and children two-years of age or older:  apply to affected area not more than three to four times daily.
  • Children under two-years of age:  consult a physician.

Additional Information:

store at room temperature

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Copper Sulfate, Echinacea Purpurea (Coneflower) Extract, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Sodium Hydroxide, Symphylum Officinale (Comfrey) Extract, Vaccinum Angustifolium (Blueberry) Extract.

Package Labeling:

MiamiBeach1MiamiBeach2

MIAMI BEACH BURN RELIEF 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71130-773
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CUPRIC SULFATE (UNII: LRX7AJ16DT)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POMEGRANATE (UNII: 56687D1Z4D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71130-773-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product12/20/201603/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/20/201603/06/2017
Labeler - Miami Beach Brands Corporation (080429811)

Revised: 10/2023
Document Id: 0741b4c9-c238-be49-e063-6294a90a17c6
Set id: 441c802f-a35b-1530-e054-00144ff88e88
Version: 2
Effective Time: 20231009
 
Miami Beach Brands Corporation