UEC MEDICAL ANTI-ITCH- hydrocortisone cream

UEC Medical Anti-Itch by

Drug Labeling and Warnings

UEC Medical Anti-Itch by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Hydrocortisone 1%......................................................Anti-itch

PURPOSE

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 be under advice and supervision of a doctor

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

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

WHEN USING

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

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than7 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

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

INDICATIONS & USAGE

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: Ask a doctor
• for external anal and genital itching, adults:
• when practical, clean the affected area with mild soap and water and rinse thoroughly
• gently dry by patting or blotting with toilet tissues 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

STORAGE AND HANDLING

Other information

• store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

cetamacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

DOSAGE & ADMINISTRATION

Distributed by:

Untied Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UEC MEDICAL ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-393
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)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-393-20	20 in 1 BOX	04/04/2016
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 65923-393-44	144 in 1 BOX	04/04/2016
2		0.9 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	04/04/2016

Labeler - United Exchange Corp. (840130579)