Cool Comfort Swab
FDA Label NDC 71453-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Naticura Inc for the product Cool Comfort (NDC 71453-211). 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, keep out of reach of children, when using this product, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Organic Witch hazel 60%

Purpose

Astringent

Uses

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

Warnings

For external use only.

Keep Out Of Reach Of Children

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

When Using This Product

  • Do  not use more than directed unless told to do so by a doctor
  • do not put directly into rectum by using fingers or any mechanical device or applicator
  • Store at room temperature 59-86o​F (15-300C)

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

Inactive Ingredients

Organic Aloe Vera gel, Organic Glycerin, Natural Grain Alcohol, Organic Jojoba, Organic essential oils of Lavender, Cypress, Geranium.

Principal Display Panel

NDC 71453-211-00

Naticura

CoolComfort

Personal Medicated Cleanisng Pads

Cools, Soothes, Comforts

Hemorrhoidal Pads with Organic Witch Hazel and Aloe

Organic non-GMO Ingredients for your safety: Paraben Free and Chemical Free

100 Moist Soft Cloth Pads

Label (100)

Label (100)


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