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Hydrocortisone by Dynarex Corporation

Medically reviewed on Jun 23, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Dynarex Corporation
NDC Code: 67777-417

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

Uses: For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to, eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and external 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 doctor if:

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product.
  • in case of bleeding when used for anal itching

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 and older:

  • apply evenly to affected area no more than 3 or 4 times dailyChildren under 2 years of age consult a doctor
  • when used for anal itching, 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. Children under 12: consult doctor before using for anal itching.

Inactive ingredients:

Cetostearyl alcohol, glyceryl monostearate, methylchloroisothiazolinone, propylene glycol, purified water, stearic acid, trolamine, white soft paraffin 

Other information:

  • store at room temperature
  • avoid excessive heat

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro 1139.jpg

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-417
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 
STEARIC ACID 
CETOSTEARYL ALCOHOL 
PARAFFIN 
GLYCERYL MONOSTEARATE 
METHYLCHLOROISOTHIAZOLINONE 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:67777-417-0128.4 g in 1 TUBE
2NDC:67777-417-020.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/07/2016
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Gopaldas Visram & Co.,Ltd858030888manufacture(67777-417)

 
Dynarex Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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