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Hydrocortisone by Kareway Product, Inc.

Medically reviewed on March 29, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0632

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
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of 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 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 us 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: 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 20 to 25 oC (68 to 77 oF)
  • see end of carton or tube crimp for lot number and expiration date

Cortizone-1 Hydrocortisone w/ Aloe aloe vera gel, beeswax, Cetyl alcohol, Dextrin, Glycerin, Light Mineral Oil, Maltodextrin,  Methylparaben, Petrolatum, Propylparaben, Sodium cetyl sulfate, Sodium lauryl sulfate, and Purified water

Hydrocortisone

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0632
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 
GLYCERIN 
LIGHT MINERAL OIL 
MALTODEXTRIN 
METHYLPARABEN 
PETROLATUM 
SODIUM CETYL SULFATE 
SODIUM LAURYL SULFATE 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:67510-0632-11 TUBE in 1 BOX
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/12/2013
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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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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