SPL v4
SPL
SPL Set ID 71c9f2f4-2188-45eb-b55e-3856ac78070b
Route
TOPICAL
Published
Effective Date 2013-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-07-10

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

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.
Active Ingredient

Hydrocortisone 1.0%

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

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.
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.
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.
Children Under 2 Years of Age
  • do not use. Consult a doctor.
Adults and Children 2 Years and Older
  • apply to affected area not more than 3 to 4 times daily.
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-FIELD TM

Made in the USA

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-FIELD TM

Made in the USA


Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Purpose

Anti-itch

Warnings

For external use only

Do Not Use (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.
Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Other Information (Other information)

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

Inactive Ingredients (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

When Using This Product (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.
For External Anal Itching: (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.
Stop Use and Ask A Doctor If (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.
Children Under 2 Years of Age (Children under 2 years of age)
  • do not use. Consult a doctor.
Adults and Children 2 Years and Older (Adults and children 2 years and older)
  • apply to affected area not more than 3 to 4 times daily.
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-FIELD TM

Made in the USA

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-FIELD TM

Made in the USA


Advanced Ingredient Data


Raw Label Data

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