Medication Guide App

Caldecort

Dosage form: cream
Ingredients: Hydrocortisone 0.284g in 28.4g
Labeler: Insight Pharmaceuticals
NDC Code: 63736-646

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.

CALDECORT®

Drug Facts

Active ingredient

Hydrocortisone USP 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations and rashes due to:

  • insect bites
  • poison ivy, poison oak, poison sumac
  • soaps and detergents
  • eczema
  • psoriasis
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • 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 or around eyes
  • for diaper rash

Stop use and ask a doctor if
  • condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone products.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

use only as directed

  • apply externally to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: Do not use, ask a doctor

Other Information
  • store at room temperature 15°–25°C (59°–77°F)
  • see box or crimp of tube for lot number and expiration date

Inactive ingredients

Aloe Vera, Cetostearyl Alcohol, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate and White Petrolatum.

QUESTIONS?

Call 1-800-344-7239 or write to Consumer Affairs at the address below

Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

For a description of all of our products visit us at www.insightpharma.com

PRINCIPAL DISPLAY PANEL - 1 OZ Box

Contains
Moisturizing ALOE VERA

Maximum Strength Without A Prescription
CALDECORT®
HYDROCORTISONE 1% Anti-Itch Cream

NET WT. 1 OZ (28.4g)

CALDECORT 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-646
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone0.284 g  in 28.4 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
Cetostearyl Alcohol 
Propylene Glycol 
Water 
Sodium Lauryl Sulfate 
Petrolatum 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-646-011 TUBE (TUBE) in 1 BOX
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/16/2009
Labeler - Insight Pharmaceuticals (176792315)

Revised: 07/2009
 
Insight Pharmaceuticals

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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