Premier Value Hydrocortisone Cream 1%

Premier Value Hydrocortisone Cream 1%
SPL v3
SPL
SPL Set ID ab95e606-69f0-1d58-e053-2a95a90a073b
Route
TOPICAL
Published
Effective Date 2020-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-09

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

For temporary relief of itching associated with minor skin irritataions, 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

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
Packaging

Questions

Call 1-866-923-4914

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Directions

Adults and children 2 years and older

  • Apply to affected area not mroe than 3 to 4 times daily.

Children under 2 years of age

  • Do not use
  • Consult a doctor

For External and 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.
Active Ingredient

Hydrocortisone 1%

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Cetyl alcohol, Edetate disodium, Glyceryl monostearate, Methylparaben, Mineral oil, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, 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 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 irritataions, 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

Purpose

Anti-itch

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
Packaging

Questions

Call 1-866-923-4914

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Directions

Adults and children 2 years and older

  • Apply to affected area not mroe than 3 to 4 times daily.

Children under 2 years of age

  • Do not use
  • Consult a doctor

For External and 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.
Active Ingredient

Hydrocortisone 1%

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Cetyl alcohol, Edetate disodium, Glyceryl monostearate, Methylparaben, Mineral oil, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, 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 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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