FAMILY CARE HYDROCORTISONE- hydrocortisone ointment

Family Care Hydrocortisone by

Drug Labeling and Warnings

Family Care Hydrocortisone 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
• psoriasis
• poison ivy, oask, or sumac
• insect bites
• detergents
• jewelry
• cosmetics
• soaps
• seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advise 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. Consult 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

ASK DOCTOR

Stop use and ask a doctor if

• conditions worsens, syptoms 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

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:
• for 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, 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 between 20° to 25°C (68° to 77°F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredietns

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos CA, 90703 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-492
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-492-14	1 in 1 CARTON	11/24/2014
1		14 g in 1 TUBE; 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	11/24/2014

Labeler - United Exchange Corp. (840130579)