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Shield and Protect Anti-Fungal

Medically reviewed on March 16, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 1.1g in 115g
Labeler: Gentell, Inc.
NDC Code: 61554-232

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Shield & Protect Anti-Fungal

Active Ingredients (per gram): Purpose

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

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

Indications for Use:
  • 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.

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:

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:
  • 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.

Carefully clean the area and pat dry thoroughly.

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

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

Supervise children in the use of this product.

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

SHIELD AND PROTECT ANTI-FUNGAL 
anti-fungal skin protectant cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-232
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1.1 g  in 115 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:61554-232-40115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2007
Labeler - Gentell, Inc. (170967876)
Establishment
NameAddressID/FEIOperations
Gentell, Inc.170967876manufacture(61554-232)

 
Gentell, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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