1. Home
  2. Labeler Index
  3. Dlc Laboratories, Inc
  4. 24286-1560
  5. Label Information: Maximum Strength Hydrocortisone

FDA Label for Maximum Strength Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR
    8. KEEP OUT OF THE REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRODUCT LABELING

Maximum Strength Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Dlc Laboratories, Inc. 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.

Active Ingredient



Hydrocortisone, USP 1%


Purpose



Antipuritic (Anti-Itch)


Uses



  • for the temporary relief of itching associated with minor itching associated with minor skin irritatitions, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings




For external use only.


Do Not Use



  • for the treatment of diaper rash. Consult a doctor
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.

When Using This Product



  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into rectum by using fingers or any medical device or applicator

Stop Use And Ask A Doctor



if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • rectal bleeding occurs

Keep Out Of The Reach Of Children.



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


Directions



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 15-30C (59-86F)


Inactive Ingredients



mineral oil, petrolatum


Product Labeling



For fast relief of itching due to:

  • Eczema and Psoriasis
  • Insect bites
  • Soaps and detergents
  • Poison Ivy and Poison Sumac
    • Maximum Strength  Hydrocortisone 1%
    For relief of itching, rashes, and skin irritations





* Please review the disclaimer below.