Shield and Protect Anti-Fungal

Manufacturer
Gentell, Inc.
Effective date
2017-03-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:49

Label at a glance#

ProductShield and Protect Anti-Fungal
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Dosage and administration

Carefully clean 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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (per gram): Purpose

Clotrimazole 1%................................Anti-Fungal

Zinc Oxide 4.25%.............................Skin Protectanct

Indications for Use:

INDICATIONS & USAGE SECTION

  • Shield & Protect Anti-Fungal Moisture Barrier Cream in a vitamin enrichsed, water insoluble, zinc-based barrier, forming a water-shedding shield that soothes irritation of compromised skin.
  • Helps treat and prevent fungal infections associated with incontinence.
  • Protect from and seals out wetness.

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Petrolatum, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Sodium Chloride, Castor Wax, Bees Wax, Paraffin, Imidazolidnyl Urea, Propylparaben, Methylparaben, Vitamin A Palmitate, Vitamin D3,

Directions:

OTC - WHEN USING SECTION

Carefully clean 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.

Warnings:

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Carefully clean the area and pat dry thoroughly.

Apply liberally to desired areas as often as necessary or when prolonged exposure is anticipated.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on children under 2 years of age uless directed by a doctor.

Supervise children in the use of this product.

OTC - PURPOSE SECTION

Shield & Protect Anti-Fungal Moisture Barrier Cream is a vitamin enriched, water insoluble, zinc-based barrier, forming a water-shedding shield that soothes irritation of compromised skin.
Helps treat fungal infections associated with incontinence.
Protects from and seals out wetness

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shield & Protect AFShield & Protect AF

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61554-232-402020-11-06C16284748780-19d75b9d0-8209-f424-e053-dadaa90a57ceShield & Protect Anti-Fungal
61554-232-402020-01-31C16284748780-19d75b9d0-8209-f424-e053-dadaa90a57ceShield & Protect Anti-Fungal

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-23261554-232-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
MINERAL OILT5L8T28FGPIACT

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
b3765cac-068b-4625-e053-2a95a90a5df94adc17fa-8f93-3d4e-e054-00144ff88e882020-11-06WarningsExact identifier
spl set id: 4adc17fa-8f93-3d4e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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