Hydrocortisone (Anti-Itch) Ointment [Cardinal Health] -

HYDROCORTISONE (ANTI-ITCH) OINTMENT [CARDINAL HEALTH]
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NDC	70000-0489-1
Set ID	884c8227-b4f3-7ef1-e053-2995a90a0ee3
Category	HUMAN OTC DRUG LABEL
Packager	Cardinal Health
Generic Name
Product Class
Product Number
Application Number	PART348

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Active Ingredient

Hydrocortisone Acetate
Purpose

Antipruritic (Anti-Itch)
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
Warnings
For external use only

If pregnant or breast-feeding,

ask a health professional before 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
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 swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
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
- Avoid excessive heat
Inactive Ingredients

Liquid Paraffin, Sorbitan Sesquioleate, White Soft Paraffin
Questions and comments?

1-888-396-2739
Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE
anti-itch ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0489
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0489-1	72 in 1 CASE	02/01/2019
1		1 in 1 BOX
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2019

Labeler - Cardinal Health (063997360)

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Medic

HYDROCORTISONE (ANTI-ITCH) OINTMENT [CARDINAL HEALTH]

If pregnant or breast-feeding,

Do not use

Stop use and ask a doctor if

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