cr-1139 hydrocortisone cream usp 1% ndc 70000-0485-1

cr-1139 hydrocortisone cream usp 1% ndc 70000-0485-1
SPL v9
SPL
SPL Set ID 8b3af210-3097-8c10-e053-2a95a90a86f1
Route
topical
Published
Effective Date 2019-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
water cetostearyl alcohol propylene glycol petrolatum stearic acid glyceryl stearate se methylchloroisothiazolinone/methylisothiazolinone mixture trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-01-18

Purpose

Antipruritic (Anti-Itch)

Description

Hydrocortisone USP 1%


Medication Information

Warnings

For external use only

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.
  • Other uses of this product should only be under the advice and supervision of a doctor.
Purpose

Antipruritic (Anti-Itch)

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.
Other Information

Store at room temperature

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Palmitostearate, Kathon, Petrolatum, Propylene Glycol, Stearic Acid, Tea Leaf, Water

Description

Hydrocortisone USP 1%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1-888-222-1222) right away.

Label Pdp

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
Active Ingredient

Hydrocortisone USP 1%

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.
  • bleeding occurs near anus when used for anal itching
If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Warnings

For external use only

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.
  • Other uses of this product should only be under the advice and supervision of a doctor.
Purpose

Antipruritic (Anti-Itch)

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.
Other Information

Store at room temperature

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Palmitostearate, Kathon, Petrolatum, Propylene Glycol, Stearic Acid, Tea Leaf, Water

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1-888-222-1222) right away.

Label Pdp (Label PDP)

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
Active Ingredient

Hydrocortisone USP 1%

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.
  • 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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