drug facts

drug facts
SPL v8
SPL
SPL Set ID b8d531eb-4012-0450-0e4b-70a808464041
Route
topical
Published
Effective Date 2020-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (10 mg)
Inactive Ingredients
anhydrous citric acid butylated hydroxyanisole carboxymethylcellulose sodium, unspecified cetyl alcohol citric acid monohydrate edetate disodium glycerin glyceryl oleate glyceryl monostearate lanolin methylparaben propyl gallate propylene glycol propylparaben water dimethicone 350 sodium benzoate sodium lauryl sulfate stearyl alcohol petrolatum xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2004-01-01

Purpose

Anti-itch

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

Uses
  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch

Directions
  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • when first opening the tube, puncture foil seal with top end of cap
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum

Description

Hydrocortisone 1%

Principal Display Panel

NDC 0573-2830-11

New Look,

SAME SIZE!

PREPARATION H ®

HYDROCORTISONE 1%

ANTI-ITCH

CREAM

Relieves

the Itch

  • Maximum StrengthWithout

    a Prescription
  • Effective Relief of Anal Itch
  • Doctor-Prescribed Ingredient

1 TUBE | NET WT 0.9 OZ (26 g)

Do Not Use

for the treatment of diaper rash. Consult a doctor.

Active Ingredient

Hydrocortisone 1%

Questions Or Comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.

When Using This Product
  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
Keep Out of Reach of Children.

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


Structured Label Content

Warnings (WARNINGS)

For external use only

Uses (USES)
  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose (PURPOSE)

Anti-itch

Directions (DIRECTIONS)
  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • when first opening the tube, puncture foil seal with top end of cap
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Other Information (OTHER INFORMATION)

store at 20-25°C (68-77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0573-2830-11

New Look,

SAME SIZE!

PREPARATION H ®

HYDROCORTISONE 1%

ANTI-ITCH

CREAM

Relieves

the Itch

  • Maximum StrengthWithout

    a Prescription
  • Effective Relief of Anal Itch
  • Doctor-Prescribed Ingredient

1 TUBE | NET WT 0.9 OZ (26 g)

Do Not Use (Do not use)

for the treatment of diaper rash. Consult a doctor.

Active Ingredient (ACTIVE INGREDIENT)

Hydrocortisone 1%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
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.


Advanced Ingredient Data


Raw Label Data

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