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Hydrocortisone by Unifirst First Aid Corporation

Medically reviewed on Apr 16, 2018

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-211

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 irritations and rashes due to

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • cosmetics
  • jewelry
  • soaps
  • detergents
  • seborrheic dermatitis
  • psoriasis

Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

  • avoid contact with the eyes
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • for 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

Other information
  • store at room temperature 59°-86°F (15°-30°C)
  • do not freeze
  • do not use any opened or torn packets

Inactive ingredient

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

Questions or Comments?

1-800-634-7680

PRINCIPAL DISPLAY PANEL – 144 unit Box Label

MEDI-FIRST

1% Hydrocortisone
Cream

Temporary relief of itching associated with
minor skin irritation, inflammation and rashes

Para el alivio temporal de la comezón asociada con leves
irritaciones, inflamaciones y sarpullidos de la piel

0.9g (1/32oz) Packets
144 per box

PRINCIPAL DISPLAY PANEL – pouch

1% HYDROCORTISONE CREAM

ANTI-ITCH CREAM

1/32oz. (0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-211
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:47682-211-7325 POUCH in 1 BOX
1NDC:47682-211-990.9 g in 1 POUCH
2NDC:47682-211-1210 POUCH in 1 BOX
2NDC:47682-211-990.9 g in 1 POUCH
3NDC:47682-211-35144 POUCH in 1 BOX
3NDC:47682-211-990.9 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(47682-211)

 
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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