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

Purpose

Antipruritic (Anti-itch)

Description

Hydrocortisone 1%


Medication Information

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.

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.

Purpose

Antipruritic (Anti-itch)

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.
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.

Description

Hydrocortisone 1%

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

Active Ingredient

Hydrocortisone 1%


Structured Label Content

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.

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.

Purpose

Antipruritic (Anti-itch)

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.
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.

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

Active Ingredient

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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