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  5. Label Information: Freds Hydrocortisone Plus 12 Moisturizers

FDA Label for Freds Hydrocortisone Plus 12 Moisturizers

View Indications, Usage & Precautions

Table of Contents

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

Freds Hydrocortisone Plus 12 Moisturizers Product Label

The following document was submitted to the FDA by the labeler of this product Fred's, 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.

Other



Drug Facts

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,
MEMPHIS, TN 38118


Active Ingredient



Hydrocortisone 1%


Purpose



Anti-itch


Uses



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

Warnings



For external use only


Do Not Use



  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When Using This Product



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

Stop Use And Ask A Doctor If



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

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



  • for itching of skin irritation, inflammation, and rashes:
    • 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: ask a doctor
    • for external anal and genital itching, adults:
      • when practical, clean 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 applying
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: ask a doctor

Other Information



  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • Store at 20° to 25° C (68° to 77° F)
  • 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 1-866-923-4914


Principal Display Panel - 28.4 G Tube Carton



MAXIMUM STRENGTH

Hydrocortisone
Cream 1%

Antipruritic (Anti-Itch)
Itch and Rash Relief

* Please review the disclaimer below.