Hydrocortisone Acetate description, usages, side effects, indications, overdosage, supplying and lots more!

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Hydrocortisone Acetate

Bentlin Products LLC
Faria Limited dba Sheffield Pharmaceuticals


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Hydrocortisone acetate USP 1.0% w/w

Purpose

Anti-itch

Uses:

For temporary relief of itching associated with minor skin irritation, inflammation and rashes due to:

  • Atopic eczema
  • Contact dermatitis from soaps, detergents or cosmetics
  • Seborrheic dermatitis
  • Psoriasis

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

Warnings

For external use only

Do not use

  • For the treatment of diaper rash
  • On children under the age of 2 except under the supervision of a doctor

When using this product

  • Avoid contact with the eyes
  • Do not begin use any other hydrocortisone product unless directed by a doctor

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

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 and older

Apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age

Do not use. Consult a doctor.

Other Information

Store between 20°-25°C (68°-77°F)

Inactive Ingredients

caprylic/capric triglyceride, caprytyl glycol, ceteareth-20, chamomillia recutitia flower extract, citric acid, glycerin, glyceryl, stearate, palmitic acid. petrolatum phenoxyethanol, stearic acid, purified water

Questions or comments?

Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at www.exederm.com

Principal Display Panel - 2 oz Carton Label

NDC 47832-205-34

exederm ®

flare control cream
for eczema & dermatitis

NET WT 2 OZ (56g)

1% Hydrocortisone Anti-Itch Cream

Hydrocortisone Acetate

Hydrocortisone Acetate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47832-205
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE HYDROCORTISONE 10 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
petrolatum
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERYL STEARATE SE
PALMITIC ACID
POLYOXYL 20 CETOSTEARYL ETHER
CHAMOMILE
ANHYDROUS CITRIC ACID
PHENOXYETHANOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 56 in 1 TUBE
2 NDC:47832-205-34 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2007-01-24


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Be sure to consult your doctor before taking any medication!
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