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Hydrocortisone by UniShield

Medically reviewed on July 28, 2017

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1mL
Labeler: UniShield
NDC Code: 49314-5801

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 CREAM

Drug Facts

Warnings

For external use only

Do not use
  • in eyes
  • for treatment of diaper rash

Stop use, as a doctor
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products

Keep out of reach of children.

If ingested, contact a Poison Control Center right away

Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2: ask a doctor

Inactive ingredients

Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES:

For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

PRINCIPLE DISPLAY PANEL

HYDROCORTISONE CREAM

1/32 oz. (0.9g)

Dist by:UniShield

San Fernando, CA 91340

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES: For temporary relief

of itching associated with

minor skin irritations, inflammation or rashes.

Other uses of product

should be only under

the advice and supervision

of a doctor.

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-5801
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
alcohol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylparaben 
water 
cetostearyl alcohol 
polysorbate 60 
PEG-150 distearate 
steareth-20 
Packaging
#Item CodePackage Description
1NDC:49314-5801-00.8 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/28/2010
Labeler - UniShield (790677053)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE

 
UniShield

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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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