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FACE VALUES HYDROCORTISONE WITH ALOE

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: HARMON STORES
NDC Code: 63940-541

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 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 use of this product should be 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

For external anal itching users

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • do not put this product into rectum by using fingers or any mechanical device or applicator
  • children under 12 years of age: consult a doctor

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

For external anal itching users

  • adults: when practical, cleanse affeted area with mild soap and warm water and 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
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

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

Distributed by Harmon Stores, Inc.

Union, NJ 07083 USA

www.facevalues.com

Made in Korea

FACE VALUES HYDROCORTISONE WITH ALOE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-541
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BUTYLATED HYDROXYTOLUENE 
PARAFFIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:63940-541-281 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2012
Labeler - HARMON STORES (804085293)

Revised: 09/2015
 
HARMON STORES

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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