HYDROCORTISONE ACETATE- hydrocortisone acetate cream 
Bentlin Products LLC

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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:

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

Principal Display Panel - 2 oz Carton Label

Principal Display Panel - 2 oz Carton Label

HYDROCORTISONE ACETATE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47832-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PALMITIC ACID (UNII: 2V16EO95H1)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CHAMOMILE (UNII: FGL3685T2X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47832-205-341 in 1 CARTON01/24/2007
156 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:47832-205-151 in 1 CARTON02/07/2018
228 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:47832-205-05576 in 1 CASE12/08/2014
35 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/24/2007
Labeler - Bentlin Products LLC (832615426)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(47832-205)

Revised: 10/2023
Document Id: 1054b185-9c83-4935-a364-9b6ce657edbc
Set id: 4346351c-8e11-46ae-b428-98d17f55beb9
Version: 5
Effective Time: 20231030
 
Bentlin Products LLC