1. Home
  2. Labeler Index
  3. Chain Drug Marketing Association
  4. 63868-099
  5. Label Information: Quality Choice Hydrocortisone

FDA Label for Quality Choice Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. FOR EXTERNAL ANAL ITCHING
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL - 28.4 G TUBE CARTON

Quality Choice Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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.

Other



Drug Facts

Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995


Active Ingredient



Hydrocortisone 1%


Purpose



Anti-itch cream


Uses



  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external genital 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



  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask A Doctor Before Use If You Have



  • a vaginal discharge
  • rectal bleeding
  • diaper rash

Otc - When Using



When using this product consult a doctor before exceeding recommended dosage


Stop Use And Ask A Doctor If



  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Otc - Keep Out Of Reach Of Children



Keep out of 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


For External Anal Itching



  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

    • Children under 12 years of age: consult a doctor


Other Information



  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients



aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).


Questions?



Call 248-449-9300


Principal Display Panel - 28.4 G Tube Carton



QC
QUALITY
CHOICE®

Maximum Strength
Hydrocortisone Cream 1%

Intensive Healing Formula†

Antipruritic (Anti-Itch)
With Antioxidants & Chamomile

1 OZ NET WT (28.4g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton - hydrocortisone 01

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton - hydrocortisone 01


* Please review the disclaimer below.