ADVANCED HYDROCORTISONE- hydrocortisone cream

Advanced Hydrocortisone by

Drug Labeling and Warnings

Advanced Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Ultra Seal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram) Hydrocortisone USP-10 mg

PURPOSE

Purpose: Antipruritic (Anti Itch)

INDICATIONS & USAGE

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema,insect bites, poison ivy, poison oak, poison sumac, detergents, cosmetics, jewelry, saborrheic dermatitis, psoriasis and scrapes. For external feminine, genital, and anal itching.  Other uses of this product should be only under the advice and supervision of a doctor.

WARNINGS

For external use only. Do not use for the treatment of diaper rash.

Consult a doctor before use if :you have a vaginal discharge (for external feminine itching).  For external itching, do not exceed the recommended daily dosage or if bleeding occurs. If condition worsens or symptoms persist more than 7 days or clear up and occur again within a few days.

When using this product:  Avoid contact with eyes, do not put this product into rectum using fingers or any mechanical device or applicator

Do not use with any other hydrocortisone product unless you have consulted a doctor

DOSAGE & ADMINISTRATION

Directions:  For adults and children 2 years of age and older: Apply to affected area not more than 3-4 times daily

Children under 2 years of age: Do not use, consult a doctor.

Adults for external itching, when practical, cleanse the affected area with mild soap and warm water and rinse th

thoroughly or by patting or blotting with an appropriate cleansing pad

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age-For external anal itching, consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients:  Citric Acid, Glycerin, Glycerol Stearate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Titanium Dioxide

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED HYDROCORTISONE  
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42213-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42213-370-09	0.9 g in 1 PACKET; Type 0: Not a Combination Product	04/05/2011
2	NDC: 42213-370-80	144 in 1 BOX	04/05/2011
2	NDC: 42213-370-34	1.5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 42213-370-28	28 g in 1 TUBE; Type 0: Not a Combination Product	04/05/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/05/2011

Labeler - Ultra Seal Corporation (085752004)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(42213-370)