Shopko Medicated Cooling
FDA Label NDC 37012-211

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc. for the product Shopko Medicated Cooling (NDC 37012-211). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)


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