FDA.reportPublic FDA data

NU CALMAR

Manufacturer
Nu Calmar Pty Ltd | Renu Laboratories, Inc.
Effective date
2022-11-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:51:22

Label at a glance#

ProductNU CALMAR
Active ingredientUNDECYLENIC ACID
Label structure7 sections

Indications and uses

Cures most Athlete's Foot, Jock Itch or Ringworm. For effective relief of itching, scaling, burning, redness, irritation, chafing associated with jock itch and itchy scaly skin between the toes.

Dosage and administration

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. For athlete's foot.  Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm , use daily for 4 weeks. ...

Label contents#

Full prescribing information#

DRUG FACTS Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 20%

Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses:

INDICATIONS & USAGE SECTION

Cures most Athlete's Foot, Jock Itch or Ringworm. For effective relief of itching, scaling, burning, redness, irritation, chafing associated with jock itch and itchy scaly skin between the toes.

Warning:

WARNINGS SECTION

For external use only. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.  

Directions:

DOSAGE & ADMINISTRATION SECTION

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. For athlete's foot. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Shea butter, Coconut Oil, Lemon Oil, Jojoba wax, Tocopherol, Grape Seed Oil, Zinc Oxide, Glycerin (Vegetable)

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250921undecylenic acid 20 % Topical CreamPSN6
1250921undecylenic acid 200 MG/ML Topical CreamSCD6
1250921undecylenic acid 20 % Topical CreamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73464-001-012025-01-30C16284748780-12cef2736-8153-d83d-e063-dadaa90ab31f0481e2c1-877b-4205-a6c0-493c6e8df7d1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73464-001-01NU CALMAR150 mL in 1 JARCREAM1506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73464-001NU CALMAR (UNDECYLENIC ACID) CREAM [NU CALMAR PTY LTD]6Legacy NDC, 1 package rows20221105_0481e2c1-877b-4205-a6c0-493c6e8df7d1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73464-00173464-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
LEMON OILI9GRO824LLIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
TOCOPHEROLR0ZB2556P8IACT
GRAPE SEED OIL930MLC8XGGIACT
ZINC OXIDESOI2LOH54ZIACT
GLYCERINPDC6A3C0OXIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
eca759ee-4199-2762-e053-2a95a90aed5a0481e2c1-877b-4205-a6c0-493c6e8df7d12022-11-04WarningsExact identifier
spl id: eca759ee-4199-2762-e053-2a95a90aed5a
spl set id: 0481e2c1-877b-4205-a6c0-493c6e8df7d1

Reported adverse events (FAERS/openFDA)#

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