HYDROCORTISONE- anti-itch ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
Cardinal Health
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antipruritic (Anti-Itch) 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
Authorization status:
OTC monograph not final
Authorization number:
70000-0489-1

HYDROCORTISONE- anti-itch ointment

Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CR-1138 Hydrocortisone Acetate 1% NDC 70000-0489-1

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

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

HYDROCORTISONE

Cardinal Health

anti-itch ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 48 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP)

SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A)

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 48 9 -1

72 in 1 CASE

0 2/0 1/20 19

1

1 in 1 BOX

1

28 .4 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 2/0 1/20 19

Labeler -

Cardinal Health (097537435)

Revised: 5/2019

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