GADADERM HYDROCORTISONE- hydrocortisone acetate cream

Gadaderm Hydrocortisone by

Drug Labeling and Warnings

Gadaderm Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                   Purpose

Hydrocortisone Acetate (0.5%)       Antiruritic (Anti-itch)

PURPOSE

Purpose

Antipruritic (Anti-itch)

INDICATIONS & USAGE

Uses



For temporary relief of minor skin irritations and rashes due to eczema, insect bites, poison oak, poison sumac, poison ivy, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itchin. Other uses of this product should be only under the advice and supervision of doctor.

WARNINGS

Warnings: For External Use Only.

Do not use

• in the eyes
• for diaper rash
• if you have vaginal discharge
• more than recommended dosage

Stop use and ask a doctor if

• the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

Ask a doctor before use if you are pregnant or breast-feeding

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

• Adults and children over 2 years of age: apply evenly to affected area no more than 3 to 4 times daily
• Children under 2 years of age: Do not use. Consult a doctor

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area up to 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.

INACTIVE INGREDIENT

Inactive ingredients Mineral oil, propylene glycol, cety stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, propylparaben

QUESTIONS

GADAL Laboratories, Inc.

Miami, Fl 33186

www.gadallaboratories.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GADADERM HYDROCORTISONE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-262
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CETEARETH-6 (UNII: 2RJS3559D3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-262-01	1 in 1 BOX
1		42.52 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2013

Labeler - Gadal Laboratories Inc (841305639)