FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Navarro Discount Pharmacies,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Hydrocortisone 1%


Purpose



Anti-itch


Uses



temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:

  • eczema
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • external feminine and anal itching
  • Other uses of this product:  ask a doctor

Warnings



For external use only


Do Not Use



  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash; ask a doctor

Ask A Doctor Or Pharmacist Before Use If You Are



using any other hydrocortisone product


When Using This Product



for external anal itching, do not exceed recommended daily dosage unless directed by a doctor


Stop Use And Ask A Doctor If



  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • rectal bleeding occurs

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control right away.


Directions



  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching:  when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 2 years, or children under 12 years with external anal itching:  do not use, ask a doctor

Other Information



  • store at room temperature, protect from freezing

Inactive Ingredient



Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water


Package Label.Principal Display Panel



Hydrocortisone


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