Rapidol Hydrocortisone 1%(dil)

Rapidol Hydrocortisone 1%(dil)
SPL v6
SPL
SPL Set ID 19a1f1e2-bc6b-7153-e063-6294a90ab115
Route
TOPICAL
Published
Effective Date 2024-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Edetate Disodium Glyceryl Monostearate Mineral Oil Water .alpha.-tocopherol Acetate Chlorocresol Sodium Metabisulfite Ceteareth-20 Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-11-04 Until 2025-01-01

Description

Active ingredient Purpose Hydrocortisone 1%............................................... Anti-itch


Medication Information

Description

Active ingredient Purpose Hydrocortisone 1%............................................... Anti-itch

Uses

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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergent
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • and for external feminine, genital, and anal itching
  • for other uses of this product should only be under the advice and supervision of a doctor
Section 55105-1
Active ingredient Purpose

Hydrocortisone 1%...............................................

Anti-itch

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Directions

For itchy skin, irritations, inflammation, rashes and external feminine and genital itching:

  • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult 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: consult a doctor

Do Not Use
  • for treatment of diaper rash. Consult a doctor
  • if you have a vaginal discharge. Consult a doctor.
  • with any other hydrocortisone product unless you have consulted a doctor
Questions?

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

Dist. By/ Por

Pharmadel LLC

New Castle, DE 19720 • www.pharmadel.com

+1-866-359-3478

Made in India / Hecho en India

†This product is not manufactured or distributed by Chattem, Inc. a division of Sanofi owner of the Cortizone-10® trademark.

Other Information
  • store in a cool dry place
  • do not use if foil seal under cap is torn, broken, or missing
Inactive Ingredients

Aloe vera, ceteareth-20, cetostearyl alcohol, chlorocresol, edetate disodium, glyceryl monostearate, mineral oil, propylene glycol, sodium metabisulfite, tocopherol acetate (vitamin E), water

Principal Display Panel

When Using This Product
  • 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 and occur again within a few days
If Pregnant Or Breastfeeding,

ask a doctor before use.

Keep Out of Reach of Children

If accidental ingestion, seek medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergent
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • and for external feminine, genital, and anal itching
  • for other uses of this product should only be under the advice and supervision of a doctor
Section 55105-1 (55105-1)
Active ingredient Purpose

Hydrocortisone 1%...............................................

Anti-itch

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Directions

For itchy skin, irritations, inflammation, rashes and external feminine and genital itching:

  • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult 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: consult a doctor

Do Not Use (Do not use)
  • for treatment of diaper rash. Consult a doctor
  • if you have a vaginal discharge. Consult a doctor.
  • with any other hydrocortisone product unless you have consulted a doctor
Questions?

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

Dist. By/ Por (Dist. by/ por)

Pharmadel LLC

New Castle, DE 19720 • www.pharmadel.com

+1-866-359-3478

Made in India / Hecho en India

†This product is not manufactured or distributed by Chattem, Inc. a division of Sanofi owner of the Cortizone-10® trademark.

Other Information (Other information)
  • store in a cool dry place
  • do not use if foil seal under cap is torn, broken, or missing
Inactive Ingredients (Inactive ingredients)

Aloe vera, ceteareth-20, cetostearyl alcohol, chlorocresol, edetate disodium, glyceryl monostearate, mineral oil, propylene glycol, sodium metabisulfite, tocopherol acetate (vitamin E), water

Principal Display Panel

When Using This Product (When using this product)
  • 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 and occur again within a few days
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a doctor before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If accidental ingestion, seek medical help or contact a Poison Control Center immediately.


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Raw Label Data

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