HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH)- hydrocortisone acetate cream

Hydrocortisone Acetate by

Drug Labeling and Warnings

Hydrocortisone Acetate by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Anti-itch cream

Uses

• temporary relief of itching associated with minor skin irritations and rashes due to
  • eczema
  • insect bites
  • poison ivy, poison oak, or poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external genital and anal itching
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the eyes
• by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

• a vaginal discharge
• rectal bleeding
• diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

• condition gets worse
• condition persists for more than 7 days
• condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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: do not use. consult a doctor

For external anal itching:

• Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other information

• To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
• store at room temperature
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

Questions?

Call 1-866-923-4914

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Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Carton

Itch and Rash Relief

Hydrocortisone 1%
Cream
Hydrocortisone Acetate
Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE ACETATE   ANTIPRURITIC (ANTI-ITCH)
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2069
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
cetostearyl alcohol (UNII: 2DMT128M1S)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium lauryl sulfate (UNII: 368GB5141J)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2069-2	1 in 1 CARTON	06/01/2001
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51672-2069-9	454 g in 1 JAR; Type 0: Not a Combination Product	06/01/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/01/2001

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2069)