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Hydrocortisone by Discount Drug Mart Inc.

Medically reviewed on December 27, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Discount Drug Mart Inc.
NDC Code: 53943-985

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.

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

  • eczema
  • insect bites
  • poison ivy, oak, sumac
  • soaps
    • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • temproarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use
  • if you area allergic to any of the ingredients
  • in the genital area 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 eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep out of reach of children

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

Directions

for itching of skin irritation, inflammation, and rashes:

  • 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: ask a doctor

for external anal and genital itching, adults:

  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

store at room temperature

Inactive ingredient

aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

Package label

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-985
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA 
CALCIUM ACETATE 
CETOSTEARYL ALCOHOL 
GLYCERIN 
MALTODEXTRIN 
MINERAL OIL 
PETROLATUM 
PROPYLPARABEN 
SODIUM CETOSTEARYL SULFATE 
SODIUM LAURYL SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53943-985-011 TUBE in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/30/2015
Labeler - Discount Drug Mart Inc. (047741335)

 
Discount Drug Mart Inc.

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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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