Rugby Hydrocortisone Cream 1% With Aloe

Rugby Hydrocortisone Cream 1% With Aloe
SPL v2
SPL
SPL Set ID 132982ea-cce6-687c-e063-6294a90a4632
Route
TOPICAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Glyceryl Mono And Dipalmitostearate Edetate Disodium Propylparaben Sorbitan Monostearate Propylene Glycol Petrolatum Aloe Vera Leaf Cetyl Alcohol Water Methylparaben Polysorbate 60 Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-08

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external feminine, 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
  • avoid contact with eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

For External Anal Itching Users:

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

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 and anal itching

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

by patting or blotting with toilet tissue or a soft cloth before application of this product.

  • 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 with external anal itching: consult a doctor.
Do Not Use
  • For the treatment of diaper rash, consult a doctor
  • For the external genital itching if you have a vaginal discharge, consult a doctor
Package Label

Active Ingredient

Hydrocortisone 1%

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral Oil, Mono and di glycerides, petrolatum, Polysorbate 60, Propylene glycol, propylparaben, purified water, sorbitan monostearate.

When Using This Product
  • avoid contact with the 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.
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Stop Using This Product and Ask A Doctor If
  • Conditions worsen
  • 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.

Structured Label Content

Uses

For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external feminine, 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
  • avoid contact with eyes
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

For External Anal Itching Users:

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton as it contains important information

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 and anal itching

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

by patting or blotting with toilet tissue or a soft cloth before application of this product.

  • 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 with external anal itching: consult a doctor.
Do Not Use
  • For the treatment of diaper rash, consult a doctor
  • For the external genital itching if you have a vaginal discharge, consult a doctor
Package Label

Active Ingredient

Hydrocortisone 1%

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral Oil, Mono and di glycerides, petrolatum, Polysorbate 60, Propylene glycol, propylparaben, purified water, sorbitan monostearate.

When Using This Product (When using this product)
  • avoid contact with the 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.
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • Conditions worsen
  • 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.

Advanced Ingredient Data


Raw Label Data

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