Cr-1138 Hydrocortisone Acetate 1% Ointment, Ndc 70000-0489-1

Cr-1138 Hydrocortisone Acetate 1% Ointment, Ndc 70000-0489-1
SPL v7
SPL
SPL Set ID 884c8227-b4f3-7ef1-e053-2995a90a0ee3
Route
TOPICAL
Published
Effective Date 2019-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01

Description

Hydrocortisone Acetate

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone Acetate

Uses

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

Label

Section 50565-1

If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.

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 finger or any mechanical device
Active Ingredient

Hydrocortisone Acetate

Other Information
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients

Liquid Paraffin, Sorbitan Sesquioleate, White Soft Paraffin

Questions and Comments?

1-888-396-2739

Stop Use and Ask A Doctor If

condition worsens or if symptoms persist 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

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 sumak, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine and anal itching

Label

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.

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 finger or any mechanical device
Active Ingredient

Hydrocortisone Acetate

Other Information
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients

Liquid Paraffin, Sorbitan Sesquioleate, White Soft Paraffin

Questions and Comments? (Questions and comments?)

1-888-396-2739

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or if symptoms persist 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

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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