FAMILY CARE HYDROCORTISONE

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: UNITED EXCHANGE CORP.
NDC Code: 65923-472

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                                                                       Purpose

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

Uses for the temporary relief of itching associated with minor skin irriations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital, feminine and anal itching.
Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Warnings

  • for external use only
  • avoid contact with eyes

Stop using this product and ask a doctor

  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

Keep this and all drugs out of the reach of children.

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

Before using any medication, read all label directions.  Keep this carton.  It contains important information.

Directions

  • for 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

Other information

  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

glycerin, propylene glycol, sodium chloride, white petrolatum, cetyl alcohol, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water

Distributed By:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

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FAMILY CARE HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-472
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
MINERAL OIL 
PROPYLPARABEN 
WATER 
SODIUM CETOSTEARYL SULFATE 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:65923-472-141 TUBE (TUBE) in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2012
Labeler - UNITED EXCHANGE CORP. (840130579)

Revised: 04/2012
 
UNITED EXCHANGE CORP.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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