WESTERN FAMILY  HYDROCORTISONE- hydrocortisone cream 
Western Family Foods Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Western Family®
HydroCortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

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:

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

For external anal itching:

Children under 12 years of age: consult a doctor

Other information

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

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
WESTERN FAMILY   HYDROCORTISONE
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-013-021 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/23/1995
Labeler - Western Family Foods Inc (192166072)
Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Phamaceuticals Inc.206263295MANUFACTURE(55312-013)

Revised: 3/2013
Document Id: 9a843f34-91ab-4890-b92d-73e0a8916f57
Set id: 33e3c823-896a-4494-be74-0fe8ba9badb1
Version: 1
Effective Time: 20130314
 
Western Family Foods Inc