Hydrocortisone Ointment, Usp 1%

Hydrocortisone Ointment, Usp 1%
SPL v5
SPL
SPL Set ID d6523993-d781-cdbc-e053-2a95a90af191
Route
TOPICAL
Published
Effective Date 2022-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
White Petrolatum Sorbitan Sesquioleate Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-17

Description

Hydrocortisone Acetate USP 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone Acetate USP 1%

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Label

Section 51945-4

Hydrocortisone Ointment, USP 1%

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.
  • Children under 12: consult a doctor before using for anal itching.
Do Not Use
  • in the eyes
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you are using any other hydrocortisone product

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 01/2022

Active Ingredient

Hydrocortisone Acetate USP 1%

Other Information
  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • Avoid excessive heat
  • Preserve in well-closed container
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Mineral Oil, Sorbitan Sesquioleate, White Petrolatum

Stop Use and Ask A Doctor If
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use


Structured Label Content

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Label

Section 51945-4 (51945-4)

Hydrocortisone Ointment, USP 1%

Purpose

Antipruritic (Anti-Itch)

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.
  • Children under 12: consult a doctor before using for anal itching.
Do Not Use (Do not use)
  • in the eyes
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you are using any other hydrocortisone product

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 01/2022

Active Ingredient (Active ingredient)

Hydrocortisone Acetate USP 1%

Other Information
  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • Avoid excessive heat
  • Preserve in well-closed container
  • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

Mineral Oil, Sorbitan Sesquioleate, White Petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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