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Dr. Sheffield Hydrocortisone Anti itch

Medically reviewed by Drugs.com. Last updated on Dec 23, 2019.

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Sheffield Pharmaceuticals LLC
NDC Code: 11527-052

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external feminine, 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
  • for the treatment of diaper rash, consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor.

When using this product
  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if
  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by 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 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 or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: consult a doctor.

Other information

store at a controlled room temperature 20 - 25ºC (68 - 77ºF).

Inactive ingredients

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

Principal Display Panel – 1oz Carton Label

Compare to the active ingredient of Cortizone‚óŹ10®*

NDC 11527-052-55

Hydrocortisone MAXIMUM STRENGTH

Net Wt. 1 oz (28g) Hydrocortisone 1% Anti-itch Cream

Dr. Sheffield's

SHEAF-FIELDTM

Made in the USA

Principal Display Panel – 1oz Tube Label

NDC 11527-052-55

Hydrocortisone MAXIMUM STRENGTH

Net Wt. 1 oz (28g) Hydrocortisone 1% Anti-itch Cream

Dr. Sheffield's

SHEAF-FIELDTM

Made in the USA

DR. SHEFFIELD HYDROCORTISONE ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BENZYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
CETYL PALMITATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
ISOSTEARYL NEOPENTANOATE 
METHYLPARABEN 
PEG-40 STEARATE 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:11527-052-551 TUBE in 1 CARTON
128 g in 1 TUBE
2NDC:11527-052-511 TUBE in 1 CARTON
214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2007
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIOperations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-052)

 
Sheffield Pharmaceuticals LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.