TheraPlus

Manufacturer
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:58:35

Label at a glance#

ProductTheraPlus Plus
Active ingredientCLOTRIMAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Clotrimazole 1%

WARNINGS SECTION

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

on the scalp or nails

When using this product

avoid contact with eyes

OTC - PURPOSE SECTION

Purpose

Antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

INDICATIONS & USAGE SECTION

  relieves itching, burning, cracking, scaling and discomfort associated with: Uses

-athletes foot      -jock itch      -ring worm

DOSAGE & ADMINISTRATION SECTION

Directions

-wash and dry affected area thoroughly

-apply a thin layer to affected area 2 times daily

-for athlete's foot and ringworm, use daily for up to 4 weeks

-for jock itch, use daily for up to 2 weeks

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN5
309367clotrimazole 10 MG/ML Topical CreamSCD5
309367clotrimazole 1 % Topical CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-003-01TheraPlusPlus35 g in 1 TUBECREAM355

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-003THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 1 package rows20231101_de75179d-1889-4823-9f39-4bebdf185d76.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H652
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H652
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785I2
LAURETH-23INACTIVE INGREDIENTN72LMW566G2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55621-00355621-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL STEARATE SEGLYCERYL STEARATE SEFCZ5MH785ICREAM / TOPICAL4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL STEARATE SEGLYCERYL STEARATE SEFCZ5MH785ICREAM / TOPICAL4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact identifier
ndc (package): 55621-003-01
ndc (product): 55621-003
ndc11 (package): 55621000301
spl id: 08ad180e-e87c-ba6f-e063-6394a90a2bc7
spl set id: de75179d-1889-4823-9f39-4bebdf185d76

Reported adverse events (FAERS/openFDA)#

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