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Hydrocortisone Ultra Strength

Medically reviewed on July 10, 2017.

Dosage form: cream
Ingredients: HYDROCORTISONE 140mg in 14g
Labeler: Personal Care Products, Inc.
NDC Code: 29500-2439

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

Drug Facts

Hydrocortisone 1%

Purpose

Anti itch

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • inset bites
  • cosmetics
  • psoriasis
  • detergents
  • soaps
  • poison ivy, oak
  • sumac
  • jewelry
  • seborrheic dermatitis
  • 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. Consult 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


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

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: ask a doctor
  • for external anal and genital itching: adults - when practical, clean the affected 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: ask a doctor

Other information
  • store between 59° and 86° F  (15° and 30° C)
  • do not use if seal on tube is punctured or missing

Inactive ingredients

aloe vera gel, celeareth-20, cetyl alcohol, cetyl palitate, glycerin, isopropyl myristate, isodecyl neopentanoate, methyl paraben, purified water

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Ultra Strength

Hydrocortisone Cream

Fast Itch and Rash relief

Helps relieve

  • Eczema
  • Seborrheic dermatitis
  • Psoriasis
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Insect bites and more


NET WT. 0.5 OZ. (14 g)

Distributed by: PERSONAL CARE PRODUCTS, LLC  Troy, Michigan 48084 U.S.A.

Code No.:MH/DRUGS/KD-313      Made in India








HYDROCORTISONE  ULTRA STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2439
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE140 mg  in 14 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
POLYOXYL 20 CETOSTEARYL ETHER 
CETYL ALCOHOL 
CETYL PALMITATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
ISODECYL NEOPENTANOATE 
METHYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:29500-2439-114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2013
Labeler - Personal Care Products, Inc. (966155082)
Registrant - Personal Care Products, Inc. (966155082)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2439)

 
Personal Care Products, Inc.

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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