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  5. Label Information: Shopko Medicated Cooling

FDA Label for Shopko Medicated Cooling

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. IF PREGNANT OR BREAST-FEEDING
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Shopko Medicated Cooling Product Label

The following document was submitted to the FDA by the labeler of this product Shopko Stores Operating Co., Llc.. 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



Witch hazel 50%


Purpose



Astringent


Uses



  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning.
  • aids in protecting irritated anorectal areas.

Warnings



For external use only.


When Using This Product



  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If



  • bleeding occurs
  • condition worsens or does not improve within 7 days

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)


If Pregnant Or Breast-Feeding



Ask a health professional before use


Directions



  • adult: cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard

    • children under 12 years of age: consult a doctor
      • Dispose of pad in trash after use.Do not flush

Other Information



  • store at room temperature 15-300C (59-86°F)
  • for vaginal care - cleanse the area by gently wiping, patting, or blotting.  Repeat as needed.
  • for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutes and repeat as needed.

Inactive Ingredients



Alcohol, Aloe, citric acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.


Principal Display Panel



SHOPKO

Compared to the active ingredients in Tucks*

Medicated Cooling Pads

hemorrhoidal pads with witch hazel

  • Fast, soothing relief from Irritation and burning
  • For hemmorhoidal and vaginal care

    • 100 pads 3.0 sq. in. (7.6 sq. cm)


    Label - 00

    Label - 00




* Please review the disclaimer below.