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Hydrocortisone by Dynarex Corporation

Medically reviewed on May 4, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Dynarex Corporation
NDC Code: 67777-415

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.

Dynarex Hydrocortisone Cream 1%

Active ingredient                                  Purpose

Hydrocortisone 1%                              Antipruritic (anti-itch)

Warnings

​For external use only

Purpose

For temporary relief of:

  • minor skin irritations

Itches and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry

and for external itching of:

  • genital
  • feminine and
  • anal itching

Do Not Use:

  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than recommended daily dosage unless directed by a doctor
  • in the rectum using fingers or any other mechanical device or applicator

Stop use and ask a physician if:

  • the condition persists or gets worse
  • symptoms clear up and appear again within a few days
  • you are pregnant or breast feeding

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:

  • apply evenly to affected area no more than 3 or 4 times daily.

Children under 2 years of age:

  • Do not use
  • consult a physician

Adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry, patting and blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after each bowel movement

Inactive ingredients:

Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, sodium betabisulphate, white soft paraffin, water (purified)

Other information:

  • store at 20 deg. to 25 deg. C (68 deg. - 77 deg. F)
  • avoid excessive heat and humidity

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro1139.jpg

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-415
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
ceteth-20 
CETOSTEARYL ALCOHOL 
EDETATE DISODIUM 
MINERAL OIL 
SODIUM METABISULFITE 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:67777-415-0128.4 g in 1 TUBE
2NDC:67777-415-020.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/02/2015
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Pvt. Ltd.650970176manufacture(67777-415)

 
Dynarex Corporation

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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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