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Quality Choice Hydrocortisone Maximum Strength

Medically reviewed on Jan 16, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Chain Drug Marketing Association Inc
NDC Code: 63868-596

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.

Active ingredient                                                                         Purpose

Hydrocortisone 1%................................................................... Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, or sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • 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

  • 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

  • conditions 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 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 between 20° to 25°C (68°-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DISTRIBUTED BY C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA

QUALITY CHOICE HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-596
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
PARAFFIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:63868-596-281 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2015
Labeler - Chain Drug Marketing Association Inc (011920774)

 
Chain Drug Marketing Association Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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