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Hydrocortisone by Dynarex Corporation

Medically reviewed on Mar 15, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Dynarex Corporation
NDC Code: 67777-237

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.

Hydrocortisone

Active Ingredient                            Purpose

Hydrocortisone USP 10 mg            Antipruritic (anti-itch)

Uses:For temporary relief of;
  • minor skin irritations, inflammation and rashes due to
  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • scrapes

and for external itching of;
  •  genital
  • feminine and
  • anal itching

  • 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 the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • in the rectum bu 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 occur 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 over 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

Other information:
  • Store at a controlled room temperature 15 deg - 30 deg C (59 deg - 86 deg F)
  • Avoid excessive heat and humidity
  • tamper evident, do not use if packet is torn, cut or open

Inactive ingredients:

citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propyl paraben, propylene glycol, purified water, sodium citrate, titanium dioxide,

Indications and Usage

For temporary relief of minor skin irritations and external itching.

Principal Display


HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-237
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
PETROLATUM 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SODIUM CITRATE 
TITANIUM DIOXIDE 
WATER 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:67777-237-0112 BOX (BOX) in 1 CASE
1144 PACKET (PACKET) in 1 BOX
10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph 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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