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Hydrocortisone by Kareway Product, Inc.

Medically reviewed on July 26, 2017

Dosage form: cream
Ingredients: HYDROCORTISONE 1h in 100g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0065

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
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • external feminine and anal itching
  • Other uses of this product: ask 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 finers 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

Directions
  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching:  when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 2 years, or children under 12 years with external anal itching:  do not use, ask a doctor

Other information
  • store at room temperature, protect from freezing

Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Hydrocortisone

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0065
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 h  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
SQUALANE 
STEARIC ACID 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:67510-0065-11 TUBE in 1 BOX
128 g in 1 TUBE
2NDC:67510-0065-51 TUBE in 1 BOX
214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/10/2011
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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