Hydrocortisone Cream 1%

Hydrocortisone Cream 1%
SPL v4
SPL
SPL Set ID a36b9275-fc3f-106a-e053-2a95a90a3beb
Route
TOPICAL
Published
Effective Date 2020-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Water Petrolatum Ceteth-20 Disodium Edta-copper Chlorocresol Mineral Oil Propylene Glycol Sodium Metabisulfite Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-16

Description

Hydrocortisone 1%

Purpose

Antipruritic (Anti-itch)


Medication Information

Purpose

Antipruritic (Anti-itch)

Description

Hydrocortisone 1%

Uses

Relieves itches and rashes due to:

  • Eczema
  • Psoriasis
  • Seborrheic dermatitis
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Insect bites
  • External anal itching
  • Soaps
  • Detergents
  • Cosmetics
  • Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Section 51945-4

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals



Baton Rouge, LA 70810



Store in a dry, cool place

Hydrocortisone 1% Cream



NDC 70512-101-30



Qty: 28.4g

Warnings

For external use only

Do not use:

  • In the eyes
  • For diaper rash
  • If you have vaginal discharge
  • More than the recommended dosage

Ask doctor before use:

  • If you are pregnant or breast feeding

Stop use and ask a doctor if:

  • Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

​When using this product:

  • Do not put this product into rectum by using fingers or any mechanical device or applicator.

Directions
  • Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
  • Children under 2 years of age - Do not use. Consult a doctor.
    • For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store between 20ºC and 25ºC (68ºFk and 77ºF)
  • avoid excessive heat and humidity
Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.


Structured Label Content

Uses

Relieves itches and rashes due to:

  • Eczema
  • Psoriasis
  • Seborrheic dermatitis
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Insect bites
  • External anal itching
  • Soaps
  • Detergents
  • Cosmetics
  • Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Section 51945-4 (51945-4)

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals



Baton Rouge, LA 70810



Store in a dry, cool place

Hydrocortisone 1% Cream



NDC 70512-101-30



Qty: 28.4g

Purpose

Antipruritic (Anti-itch)

Warnings

For external use only

Do not use:

  • In the eyes
  • For diaper rash
  • If you have vaginal discharge
  • More than the recommended dosage

Ask doctor before use:

  • If you are pregnant or breast feeding

Stop use and ask a doctor if:

  • Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

​When using this product:

  • Do not put this product into rectum by using fingers or any mechanical device or applicator.

Directions
  • Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
  • Children under 2 years of age - Do not use. Consult a doctor.
    • For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store between 20ºC and 25ºC (68ºFk and 77ºF)
  • avoid excessive heat and humidity
Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.


Advanced Ingredient Data


Raw Label Data

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