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  5. Label Information: Hydrocortisone Ultra Strength

FDA Label for Hydrocortisone Ultra Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PRODUCT LABEL

Hydrocortisone Ultra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Personal Care Products, 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



Drug Facts

Hydrocortisone 1%


Purpose



Anti itch


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.


Uses



temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • inset bites
  • cosmetics
  • psoriasis
  • detergents
  • soaps
  • poison ivy, oak
  • sumac
  • jewelry
  • 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


      • 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

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



  • store between 59° and 86° F  (15° and 30° C)
  • do not use if seal on tube is punctured or missing

Inactive Ingredients



aloe vera gel, celeareth-20, cetyl alcohol, cetyl palitate, glycerin, isopropyl myristate, isodecyl neopentanoate, methyl paraben, purified water


Product Label



DRUGSTORE-Rx

SMART WELLNESS

Ultra Strength

Hydrocortisone Cream

Fast Itch and Rash relief

Helps relieve

  • Eczema
  • Seborrheic dermatitis
  • Psoriasis
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Insect bites and more


    • NET WT. 0.5 OZ. (14 g)

    Distributed by: PERSONAL CARE PRODUCTS, LLC  Troy, Michigan 48084 U.S.A.

    Code No.:MH/DRUGS/KD-313      Made in India


    PC Hydrocortisone1 Label - PC Hydrocortisone1

    PC Hydrocortisone1 Label - PC Hydrocortisone1








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