WESTERN FAMILY HYDROCORTISONE- hydrocortisone cream

Western Family by

Drug Labeling and Warnings

Western Family by is a Otc medication manufactured, distributed, or labeled by Western Family Foods Inc, Taro Phamaceuticals U.S.A., Inc., Taro Phamaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

• temporary relief of itching associated with minor skin irritations and rashes due to
  • eczema
  • insect bites
  • poison ivy, poison oak, or poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external 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

• in the eyes
• by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

• a vaginal discharge
• rectal bleeding
• diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

• condition gets worse
• condition persists for more than 7 days
• condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

Directions

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: do not use. consult a doctor

For external anal 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 application of this product

Children under 12 years of age: consult a doctor

Other information

• To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
• store at room temperature
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

Questions?

Call 1-866-923-4914

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Proudly Distributed By:
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

HydroCortisone
1% Hydrocortisone Anti-Itch CREAM

NET WT 1 OZ (28g)

MAXIMUM STRENGTH

INGREDIENTS AND APPEARANCE

WESTERN FAMILY   HYDROCORTISONE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-013
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
cetostearyl alcohol (UNII: 2DMT128M1S)
sodium lauryl sulfate (UNII: 368GB5141J)
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
stearyl alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-013-02	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/23/1995

Labeler - Western Family Foods Inc (192166072)

Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Phamaceuticals Inc.		206263295	MANUFACTURE(55312-013)