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 Jhk Inc Dba American Safety & First Aid. 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 Ingredient
Hydrocortisone acetate 1%
Purpose
Anti-Itch Cream
Use
Temporarily relieves itching associated with minor skin irritations and rashes due to:
- Eczema
- Insect Bites
- Poison Ivy, Oak or Sumac
- Soaps, Detergents or Cosmetics
- Jewelry
Warnings
For external use only
Do Not Use
- With any other hydrocortisone product unless you have consulted a doctor
- For the treatment of diaper rash, consult a doctor
Stop Use And Ask A Doctor If
- Condition worsens
- Symptoms persist for more than seven days
- Symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children two years and over: apply to affected area not more than three to four times daily
- Children under two years: Do not use
Other Information
- Do not use if packet is torn, cut or opened
- Store at room temperature (do not freeze)
- See packet for Lot Number and expiration date
Inactive Ingredient
Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, Water
Questions?
1-866-651-3660 Monday-Friday
8:00am-5:00pm EST
Principal Display Panel - 25 Packet Carton
Product #1014
Hydrocortisone Cream
USP 1%
For the temporary relief of itching
associated with minor skin
irritations and rashes.
25 - Unit Dose Packets
* Please review the disclaimer below.
