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Hydrocortisone by Discount Drug Mart, Inc.

Medically reviewed on Dec 27, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Discount Drug Mart, Inc.
NDC Code: 53943-984

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 sin irritation, inflammation and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • temporarily 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 are allergic to any of the ingredients
  • in the gential area if you have a vaginal discharge. Consult a doctor
  • for the treatment diaper rash: Ask 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 finders or any mechanical devices 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 day, 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 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: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years age. Ask a doctor

Other information
  • store at 20° to 25°C (63° to 77°F)
  • see end of carton or tube crimp for lot number and expiration date

Butylated hydroxytoluene, Cetyl alcohol, Glycerin, Glyceryl monostearate, Isopropyl myristate, Methylparaben,Propylparaben, Purified water, Squalane, Stearic acid

Hydrocortisone

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-984
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
SQUALANE 
STEARIC ACID 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:53943-984-011 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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