Thera Plus Maximum Strength Feminine Anti-Itch Cream

Manufacturer
FOURSTAR GROUP USA, INC.
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:07

Label at a glance#

ProductThera Plus Maximum Strength Feminine Anti-Itch
Active ingredientBENZOCAINE, RESORCINOL
Label structure7 sections

Indications and uses

temporarily relieves itching

Dosage and administration

Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily. Children under 12 years: ask a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%
Resorcinol 3%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days.

Do not applyover large areas of the body.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and older:apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily.
  • Children under 12 years:ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at 20° - 25° C (68° - 77° F).

Inactive ingredientsa

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, cetyl alcohol, cholecalciferol, edetate disodium, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, mineral oil, petrolatum, propylene glycol, retinol, sodium lauryl sulfate, sodium sulfite, tocopherol, water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSN2
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCD2
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-142-00Thera Plus Maximum Strength Feminine Anti-Itch28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-142THERA PLUS MAXIMUM STRENGTH FEMININE ANTI-ITCH (BENZOCAINE, RESORCINOL) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20250228_0007e3ea-882b-4000-8e70-2bcec2c08613.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-14280684-142-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
ndc (package): 80684-142-00
ndc (product): 80684-142
ndc11 (package): 80684014200
spl id: 2f0c45da-c4f2-bd12-e063-6394a90aba99
spl set id: 0007e3ea-882b-4000-8e70-2bcec2c08613

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.