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Hydrocortisone Anti-Itch by Universal Distribution Center LLC

Medically reviewed on April 16, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 0.01g in 1g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-022

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.

Hydrocortisone Anti-Itch Cream

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations 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 uses or the use of the product for more than 7 days should be undertaken 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  to 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
  • before using on children under 2 years of age

Keep this and all drugs out of 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

  • 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:

  • Adult: when practical, cleanse 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 application of this product
  • Children under 12 years of age: consult a doctor

Other information

  • Store at room temperature
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

HYDROCORTISONE ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
PROPYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
PETROLATUM 
GLYCERYL MONOSTEARATE 
POLYSORBATE 60 
SORBITAN MONOSTEARATE 
METHYLPARABEN 
PROPYLPARABEN 
EDETATE SODIUM 
Packaging
#Item CodePackage Description
1NDC:52000-022-371 TUBE in 1 BOX
1NDC:52000-022-3614 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-022)

 
Universal Distribution Center LLC

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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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