FDA Label for Bikini Zone Medicated Gel

View Indications, Usage & Precautions

Bikini Zone Medicated Gel Product Label

The following document was submitted to the FDA by the labeler of this product Kingsway Pharmaceuticals Dba Nfi, Llc. 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.

Active Ingredients



Lidocaine HCL 2.0% w/w


Purpose



Topical Analgesic


Uses



For temporary relief of pain and itching.


Warnings



For external use only

Avoid contact with eyes


Do Not Use



in large quantities, particularly over raw surfaces or blistered areas


Stop Use And Ask A Doctor If



  • •Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

Keep Out Of Reach Of Children



  • •If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions



For adults and children two-years or older: Apply to affected area not more then 3 to 4 times daily. Children under 2 years of age: consult a physician.


Other Information



Protect this product from excessive heat and direct sun.
Store at room temperature 15°-25°C (59°-77°F)


Inactive Ingredients



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Camphor, Ethylhexylglycerin, Glycerin, Menthol, Phenoxyethanol, Propylene Glycol, Salicylic Acid, SD Alcohol 40-B, Sodium Phytate, Triethanolamine, Water, Yarrow Extract, Yucca Extract


Questions Or Comments?



(888) 990-2454


Package/Label Principal Display Panel – Carton Label



Bikini Zone®
 
SOOTHING
MEDICATED
GEL
 
For use after any type
of hair removal
 
LIDOCAINE
Topical Analgesic
 
Instantly
relieves pain
associated with:

  • ✓Waxing
  • ✓Shaving
  • ✓Electrolysis
  • ✓Depilation
  •  
    HELPS RELIEVE
    BIKINI BUMP IRRITATION
     
    NET WT. 1 OZ (28 G)
     
     
    Distributed By:
    Kingsway Pharmaceuticals
    dba NFI Consumer Products

    636 Shelby Street, Suite 300
    Bristol, TN 37620
     
    Made in the U.S.A


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