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Hydrocortisone by First Aid Only, Inc

Medically reviewed on June 11, 2018

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: First Aid Only, Inc
NDC Code: 62985-5125

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 Ingredients

Hydrocortisone 1.0%

Purpose

Anti-itch

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.

Warnings

For external use only

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

Stop use, ask 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 dally
  • children under 2: ask a doctor

Inactive Ingredients

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

Principal Display Panel - Packet Label

Anti-Itch
Cream

0.9g (1/32 OZ)

FIRST AID ONLY.

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

© 2015 Acme United Corporation.

810002-revA

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62985-5125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
alcohol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylparaben 
water 
white wax 
Packaging
#Item CodePackage Description
1NDC:62985-5125-10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/10/2015
Labeler - First Aid Only, Inc (196551634)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(62985-5125)

 
First Aid Only, 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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