DR. SHEFFIELD HYDROCORTISONE ANTI ITCH- hydrocortisone cream 
Sheffield Pharmaceuticals LLC

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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:

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●10®*

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 Carton Label

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

Principal Display Panel – 1oz Tube Label
DR. SHEFFIELD HYDROCORTISONE ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-052-551 in 1 CARTON07/10/2007
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11527-052-511 in 1 CARTON07/10/2007
214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/10/2007
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-052)

Revised: 10/2023
Document Id: 73503439-5ce2-480b-bf3f-9362a31c8e29
Set id: 71c9f2f4-2188-45eb-b55e-3856ac78070b
Version: 4
Effective Time: 20231030
 
Sheffield Pharmaceuticals LLC