Shopko Maximum Strength Medicated
FDA Label NDC 37012-121

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 Maximum Strength Medicated (NDC 37012-121). 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, directions, 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 disconfort 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)

Directions

  • adult: unfold wipe and 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
  •  Dispose of wipe in trash.
  • For best results, only flush one or two wipes at a time.

Other Information

  • store at room temperature 20-25°C (68-77°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 desire 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

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


Principal Display Panel

SHOPKO

Maximum Strength

Medicated Wipes

with Aloe and Witch Hazel

Cools, Soothes and Cofmorts

For Hemorrhoidal and vaginal Care

Convenient, Easy to use, Flushable Wipes

48 Wipes

6 in. x 5 in. (15.2 cm x 12.7 cm)

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