Label: AFASSCO 1% HYDROCORTISONE- hydrocortisone ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated January 12, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    Drug Facts - Hydrocorticone Cream 1%
  • ACTIVE INGREDIENT
    Active Ingredients (In Each Gram) Hydrocortisone 1%
  • PURPOSE
    Purpose  Anti-itch
  • INDICATIONS & USAGE
    Uses: for the temporary temporarily relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps ...
  • WARNINGS
    Warnings - for external use only
  • ASK DOCTOR
    Consult a doctor: before use if you have a vaginal discharge (for external feminine itching) for external itching, do not exceed the recommended daily dosage or if bleeding occurs - if condition ...
  • WHEN USING
    When using this product: avoid contacty with eyes - do not put this produce into rectum by using fingers or any mechanical device or applicator
  • DO NOT USE
    Do not use: with any other Hydrocortisone product unless you have consulted a doctor
  • KEEP OUT OF REACH OF CHILDREN
    KEEP OUT OF REACH OF CHILDREN.  If swallowed contact a Poison Control center right away.
  • DOSAGE & ADMINISTRATION
    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 - • Adults for ...
  • OTHER SAFETY INFORMATION
    Other Information: Store at controlled room temperature 15° to 30° C (59° to 86° F) Tamper evident.  Do not use if packet is torn, cut, or opened. Avoid excessive heat and humidity
  • INACTIVE INGREDIENT
    Inactive Ingredients - Water, Cetearyl Alcohol, Glycerin, Ceteareth-20, Isopropyl Myristate, EDTA-2NA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice
  • Principal Display Panel
    Afassco¦ ¦® The First Choice - in First Aid - MAXIMUM STRENGTH - HYDROCORTISONE - PLUS MOISTURIZING ALOE - 1% ANTI-ITCH ANALGESIC • FOR THE - TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS - No ...
  • INGREDIENTS AND APPEARANCE
    Product Information