Perrigo Hydrocortisone Cream 1% Drug Facts

Perrigo Hydrocortisone Cream 1% Drug Facts
SPL v1
SPL
SPL Set ID 96a2d2c6-cc01-4df3-a572-fff39334d91e
Route
TOPICAL
Published
Effective Date 2017-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Palmitate Glycerin Isopropyl Myristate Methylparaben Water Isostearyl Neopentanoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-04-13

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 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
  • seborrheic dermatitis
  • soaps
  • external 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

Directions

adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

children under 2 years of age:

  • do not use. Ask a doctor.

for external anal itching:

  • adults: when practical, cleanse 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 application of this product.
  • children under 12 years of age with external anal itching: ask a doctor
Do Not Use
  • for the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions Or Comments?

1-800-719-9260

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

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

Principal Display Panel 28 G Tube Label

CommUnityCare Federally Qualified Health Centers

HYDROCORTISONE

1% CR 28g

Date:

Name:

Dr.

USE AS DIRECTED.

1/1/01

123456

HYDROCORTISONE 1% CRM 30G NDC 76413-339-28

Batch: 123456

Lot: 123456

Exp: 1/1/01

PERRIGO

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


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
  • seborrheic dermatitis
  • soaps
  • external genital and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch

Warnings

For external use only

Directions

adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

children under 2 years of age:

  • do not use. Ask a doctor.

for external anal itching:

  • adults: when practical, cleanse 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 application of this product.
  • children under 12 years of age with external anal itching: ask a doctor
Do Not Use (Do not use)
  • for the treatment of diaper rash. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not begin use of any other hydrocortisone product unless you have asked a doctor
  • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
  • do not put this product 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)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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.

Principal Display Panel 28 G Tube Label (PRINCIPAL DISPLAY PANEL - 28 g Tube Label)

CommUnityCare Federally Qualified Health Centers

HYDROCORTISONE

1% CR 28g

Date:

Name:

Dr.

USE AS DIRECTED.

1/1/01

123456

HYDROCORTISONE 1% CRM 30G NDC 76413-339-28

Batch: 123456

Lot: 123456

Exp: 1/1/01

PERRIGO

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


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