FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Acme United Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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 of supervision of a doctor.


Warnings



For external use only


Do Not Use



  • in eyes
  • for treatment of dipper 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 5 times daily
  • children under 2: as a doctor

Inactive Ingredients



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


Principal Display Panel - 0.9G Carton Label



18-012
MISC

FIRST AID ONLY®

Hydrocortisone
Anti-Itch Cream
12 (0.9g) Packets

Ungüento con hidrocortisona para aliviar la comezón
12 sobres de (0.9g)


Principal Display Panel - 0.9G 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


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