Dr. Sheffield Hydrocortisone Anti itch

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

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.

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 - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(11527-052)

Revised: 01/2013
 
Faria LLC dba Sheffield Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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