hydrocortisone by Padagis Israel Pharmaceuticals Ltd HYDROCORTISONE cream

hydrocortisone by

Drug Labeling and Warnings

hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Padagis Israel Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• insect bites
• poison ivy, oak, or sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
• rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• for itching of skin irritation, inflammation, and rashes:
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor
• for external anal and genital itching, adults:
• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Inactive ingredients

water, cetearyl alcohol, ceteareth-20, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, aloe barbadensis leaf juice

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Cortaid® active ingredient

Hydrocortisone Cream 1%

Anti-Itch Cream Maximum Strength

NET WT 1 LB (454 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45802-438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45802-438-03	1 in 1 CARTON	05/06/2011
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 45802-438-05	1 in 1 CARTON	05/10/2011
2		454 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 45802-438-70	144 in 1 CARTON	09/01/2011	09/16/2015
3		.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/13/2011

Labeler - Perrigo New York Inc (078846912)