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 Walgreens Co.. 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(S)



Hydrocortisone, USP 1%


Purpose



Anti-itch


Use(S)



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
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external 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



  • for external feminine itching if you have a vaginal discharge.  Consult a doctor.
  • for the treatment of diaper rash.  Consult a doctor.

When Using This Product



  • avoid contact with the eyes
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • for external anal itching:
  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • symptoms last for more than 7 days
  • the condition gets worse, symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly

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 do not use, consult a doctor.

For external anal itching

Adults: when practical, clean the affected 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 12 years of age: consult a doctor


Other Information



  • Store at room temperature 590-860F (150-300C). Protect from freezing. 
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient



cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax, May contain citric acid or sodium citrate solution to adjust pH.


Questions?



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