Private Label Antifungal Barrier Cream

Manufacturer
Swiss-American CDMO, LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:11

Label at a glance#

ProductPrivate Label Antifungal Barrier Cream
Active ingredientMICONAZOLE NITRATE
Label structure6 sections

Dosage and administration

Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea sorporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice dai...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Not intended for ingestion. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the treatment of jock itch: if irritation occurs or there is no improvement within 2 weeks discontinue use and consult a doctor. Do not use for diaper rash. Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Use and Directions

INDICATIONS & USAGE SECTION

Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea sorporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. 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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2.00%

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Allantoin, Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Fragrance, Hydrogenated Castor Oil, Isopropyl Palmitate, Methylparaben, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride, Zinc Oxide

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL009 ArtworkPL009 Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN4
998483miconazole nitrate 20 MG/ML Topical CreamSCD4
998483miconazole nitrate 2 % Topical CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-0009-2Private Label Antifungal Barrier Cream60 g in 1 TUBECREAM604
60232-0009-4Private Label Antifungal Barrier Cream120 g in 1 TUBECREAM1204
60232-0009-5Private Label Antifungal Barrier Cream150 g in 1 TUBECREAM1504

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-000960232-0009-2, 60232-0009-4, 60232-0009-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
ndc (package): 60232-0009-5
ndc (package): 60232-0009-2
ndc (package): 60232-0009-4
ndc (product): 60232-0009
ndc11 (package): 60232000902
ndc11 (package): 60232000904
ndc11 (package): 60232000905
spl id: e08800a5-05ac-44be-8dc0-33ecb00aac38
spl set id: e74bddea-c1ac-4e4e-84bd-5a9defb85b2d

Reported adverse events (FAERS/openFDA)#

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