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

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

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
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

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

Description

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

Principal Display Panel

Questions?

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

Section 55105-1
Active ingredient Purpose

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

Anti-itch

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
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.

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

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

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
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

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

Questions?

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

Section 55105-1 (55105-1)
Active ingredient Purpose

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

Anti-itch

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
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.

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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