Bikini Zone Medicated Gel
FDA Label NDC 69993-044

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingsway Pharmaceuticals Dba Nfi, Llc for the product Bikini Zone Medicated Gel (NDC 69993-044). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    Image-01 (Image 01)

    Image-01 (Image 01)

* Please review the disclaimer below.