SHOPKO  HYDROCORTISONE- hydrocortisone ointment 
Shopko Stores Operating Co., LLC

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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Shopko®
Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

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 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 and ask a doctor if

  • condition worsens, symptoms 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC 37012-018-02

SHOPKO®
Maximum Strength

Hydrocortisone Ointment 1%

Antipruritic (Anti-Itch)

Itch & Rash Relief

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
SHOPKO   HYDROCORTISONE
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-018
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
Medium-chain triglycerides (UNII: C9H2L21V7U)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-018-021 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/03/1989
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(37012-018)

Revised: 5/2014
Document Id: de30ed6d-e1ee-4c75-8a68-0ad992991039
Set id: 92bcbde3-401a-4301-854e-c352852317d6
Version: 1
Effective Time: 20140502
 
Shopko Stores Operating Co., LLC