Uec Medical Anti-Itch (Hydrocortisone) Cream [United Exchange Corp.] -

UEC MEDICAL ANTI-ITCH (HYDROCORTISONE) CREAM [UNITED EXCHANGE CORP.]
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NDC	65923-393-20, 65923-393-44
Set ID	6923f646-220a-bc32-e053-2a91aa0a8bd4
Category	HUMAN OTC DRUG LABEL
Packager	United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number	PART348

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/04/2016

Labeler - United Exchange Corp. (840130579)

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