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Hydrocortisone by Dynarex Corporation

Medically reviewed on April 5, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Dynarex Corporation
NDC Code: 67777-224

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 Acetate 1%            Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

Use:

  • For the 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 for external genital, feminine, and anal itching.

Do not use:
  • in the eyes 
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any mechanical device or applicator

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

Keep out of reach of children

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 to affected area not more than 3 to 4 times daily. Children 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 or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.

Other information:
  • Store at room temperature
  • Avoid excessive heat

Inactive ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified water, White Soft Paraffin.

For the 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 for external genital, feminine, and anal itching.

Principal Display Panel

1137 Hydro Cort.jpg

HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-224
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
CETETH-20 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
MINERAL OIL 
PETROLATUM 
SODIUM METABISULFITE 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:67777-224-0128.3 g in 1 TUBE
2NDC:67777-224-020.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/02/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

 
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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