FDA.reportPublic FDA data

Bikini Zone Medicated Gel

Manufacturer
Kingsway Pharmaceuticals dba NFI, LLC
Effective date
2025-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:33

Label at a glance#

ProductBikini Zone Medicated Gel
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For temporary relief of pain and itching.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 2.0% w/w

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching.

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

(888) 990-2454

Package/Label Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69993-044-01Bikini Zone Medicated Gel1 in 1 CARTONGEL11
69993-044-01Bikini Zone Medicated Gel28 g in 1 TUBEGEL281

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69993-04469993-044-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SALICYLIC ACIDO414PZ4LPZIACT
ALCOHOL3K9958V90MIACT
PHYTATE SODIUM88496G1ERLIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKIACT
YUCCA SCHIDIGERA WHOLE08A0YG3VICIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bikini Zone Medicated GelLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC30b85890-e72d-4af7-bda9-e7744abc92af2025-08-29WarningsExact identifier
ndc (package): 69993-044-01
ndc (product): 69993-044
ndc11 (package): 69993004401
spl id: 30b85890-e72d-4af7-bda9-e7744abc92af
spl set id: 30b85890-e72d-4af7-bda9-e7744abc92af