WESTERN FAMILY  HYDROCORTISONE PLUS 12 MOISTURIZERS- 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 Plus 12 Moisturizers

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

  • 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

Inactive ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

Questions?

Call 1-866-923-4914

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 PLUS
12 MOISTURIZERS

NET WT 1 OZ (28g)
MAXIMUM STRENGTH

Principal Display Panel - 28 g Tube Carton
WESTERN FAMILY   HYDROCORTISONE PLUS 12 MOISTURIZERS
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-063
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)  
chamomile flower oil (UNII: 60F80Z61A9)  
citric acid monohydrate (UNII: 2968PHW8QP)  
corn oil (UNII: 8470G57WFM)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
maltodextrin (UNII: 7CVR7L4A2D)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Vitamin A palmitate (UNII: 1D1K0N0VVC)  
cholecalciferol (UNII: 1C6V77QF41)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-063-021 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/03/1989
Labeler - Western Family Foods Inc (192166072)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(55312-063)

Revised: 3/2013
Document Id: 487d7e98-cead-45d5-b338-9df3d93e2e96
Set id: 45be083c-5330-4526-8378-db67243408c6
Version: 1
Effective Time: 20130314
 
Western Family Foods Inc