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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

  • temporarily relieves itching associated with minor skin irriations, inflammation and rashes due to:
  • eczema
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • temporarily relieves external anal and genitcal itching
  • other use of this product should be only 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 the 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: consult a doctor

  • For external anal and genitcal itching, 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 applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other information

  • store at room temperature 20°-25°C (68°-77°F)
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

alove vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Distributed by

Liberty Procurement, Inc.

650 Liberty Ave.

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 
CETETH-20 
CETYL ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WATER 
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: 10/2016
 
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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