SPL v6
SPL
SPL Set ID b68f8ada-58e8-e8e4-e053-2a95a90ab02d
Route
TOPICAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Phenoxyethanol Prasterone Aloe Vera Leaf Polysorbate 60 Tocopherol Stearic Acid Coconut Oil Jojoba Oil Water Sunflower Oil Xanthan Gum Glycerin Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Hydrocortisone Acetate 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone Acetate 1%

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

  • Eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Warnings

For external use only

Do Not Use
  • for the treatment of diaper rash
  • if pregnant or nursing - consult a doctor
  • in the genital area if you have a vaginal discharge - consult a doctor
Directions

FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES

  • adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily

FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS

  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 2 to 3 times daily
  • Ages 12 to 18 years: ask a doctor
Drug Facts

Hydrocortisone Acetate 1%

Other Information

Contents filled by weight, not volume

Inactive Ingredients

Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum

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 or persists for more than 7 days
  • if condition clears up and occurs again
  • if rectal bleeding occurs
  • before using any other hydrocortisone product
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Front Display Panel and Back Card

NEW!

FORMULATED TO HEAL ITCH AND PROTECT COLLAGEN

STEROID POWER

FAST ACTING

  • Rash
  • Poison Ivy
  • Eczema
  • Insect Bites
  • Psoriasis
  • Inflammation

UNIQUE PATENTED FORMULA

ZCort ULTRA+ ANTI-ITCH CREAM

NET WT 0.5 OZ (15g)

ACTIVE INGREDIENT: HYDROCORTIZONE 1% WITH DHEA

see zcortfront.jpg

ZCort Ultra+ ANTI-ITCH CREAM BACK CARD

see zcortbackbox.jpg


Structured Label Content

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

  • Eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Purpose

Anti-Itch

Warnings

For external use only

Do Not Use (DO NOT USE)
  • for the treatment of diaper rash
  • if pregnant or nursing - consult a doctor
  • in the genital area if you have a vaginal discharge - consult a doctor
Directions

FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES

  • adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily

FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS

  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 2 to 3 times daily
  • Ages 12 to 18 years: ask a doctor
Drug Facts

Hydrocortisone Acetate 1%

Other Information

Contents filled by weight, not volume

Inactive Ingredients

Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum

When Using This Product (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 (STOP USE AND ASK A DOCTOR)
  • if condition worsens or persists for more than 7 days
  • if condition clears up and occurs again
  • if rectal bleeding occurs
  • before using any other hydrocortisone product
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away

Front Display Panel and Back Card

NEW!

FORMULATED TO HEAL ITCH AND PROTECT COLLAGEN

STEROID POWER

FAST ACTING

  • Rash
  • Poison Ivy
  • Eczema
  • Insect Bites
  • Psoriasis
  • Inflammation

UNIQUE PATENTED FORMULA

ZCort ULTRA+ ANTI-ITCH CREAM

NET WT 0.5 OZ (15g)

ACTIVE INGREDIENT: HYDROCORTIZONE 1% WITH DHEA

see zcortfront.jpg

ZCort Ultra+ ANTI-ITCH CREAM BACK CARD

see zcortbackbox.jpg


Advanced Ingredient Data


Raw Label Data

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