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Hydrocortisone by Unifirst First Aid Corporation

Medically reviewed on April 16, 2018

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-933

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 (in each gram)

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

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

Warnings

For external use only

Do not use
  • in the eyes
  • to treat a diaper rash
  • this or any other hydrocortisone product unless you have consulted a doctor

Stop use and ask a doctor if
  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

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

Directions

Adults and children 2 years and over:
  • apply to affected area not more than 3 to 4 times daily

Children under 2 years:
  • do not use, consult a doctor

Other information
  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

1% HYDROCORTISONE CREAM

ANTI-ITCH CREAM

1/32oz. (0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA

PRINCIPAL DISPLAY PANEL – 25 unit Box Label

MEDI-FIRST
Plus

Hydrocortisone Cream 1%

25 units of 1/32 oz (0.9g) Packets

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-933
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:47682-933-7325 POUCH in 1 BOX
10.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2013
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(47682-933)

 
Unifirst First Aid Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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