1137 Hydrocortisone Cream Ndc 67777-003-01

1137 Hydrocortisone Cream Ndc 67777-003-01
SPL v7
SPL
SPL Set ID 81ccb562-0cbc-07e4-e053-2a91aa0aaea3
Route
TOPICAL
Published
Effective Date 2018-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Mineral Oil Cetostearyl Alcohol Chlorocresol Edetate Disodium Anhydrous Propylene Glycol Bisulfite Ion Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-03

Description

Hydrocortisone Acetate 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone Acetate 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.

Section 50565-1

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

Warnings

For external use only

1137 Label

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 time 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 yes
  • 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 rectumby using fingers or any mechanical device or applicator
Active Ingredient

Hydrocortisone Acetate 1%

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

Ceteareth-20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium Metabisulfite, Water, 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, and do not use this or any other hydrocortisone product.
  • in case of bleeding 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 sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

Section 50565-1 (50565-1)

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

Purpose

Antipruritic (Anti-Itch)

Warnings

For external use only

1137 Label

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 time 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 yes
  • 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 rectumby using fingers or any mechanical device or applicator
Active Ingredient

Hydrocortisone Acetate 1%

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

Ceteareth-20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium Metabisulfite, Water, 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, and do not use this or any other hydrocortisone product.
  • in case of bleeding 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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