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Hydrocortisone Acetate by Bentlin Products LLC

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 10mg in 1g
Labeler: Bentlin Products LLC
NDC Code: 47832-205

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:47832-205
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
PETROLATUM 
MEDIUM-CHAIN TRIGLYCERIDES 
GLYCERYL STEARATE SE 
PALMITIC ACID 
POLYOXYL 20 CETOSTEARYL ETHER 
CHAMOMILE 
ANHYDROUS CITRIC ACID 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:47832-205-341 TUBE in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/24/2007
Labeler - Bentlin Products LLC (832615426)
Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(47832-205)

Revised: 10/2013
 
Bentlin Products LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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