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?
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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
* Please review the disclaimer below.
