SHIELD AND PROTECT ANTI-FUNGAL- anti-fungal skin protectant cream

Shield and Protect Anti-Fungal by

Drug Labeling and Warnings

Shield and Protect Anti-Fungal by is a Otc medication manufactured, distributed, or labeled by Gentell, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

INACTIVE INGREDIENT

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.

DOSAGE & ADMINISTRATION

Carefully clean the area and pat dry thoroughly.

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

KEEP OUT OF REACH OF CHILDREN

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

Supervise children in the use of this product.

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHIELD AND PROTECT ANTI-FUNGAL 
anti-fungal skin protectant cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61554-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1.1 g  in 115 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61554-232-40	115 g in 1 TUBE; Type 0: Not a Combination Product	03/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2007

Labeler - Gentell, Inc. (170967876)

Establishment
Name	Address	ID/FEI	Business Operations
Gentell, Inc.		170967876	manufacture(61554-232)