Signature Care Medicated Cooling Cloth
FDA Label NDC 21130-928

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Signature Care Medicated Cooling (NDC 21130-928). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ Storage And Handling

→ Inactive Ingredient

→ Dosage & Administration

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active ingredient Purpose

Witch hazel 50%.........................................Astringent

Otc - Purpose

Uses

temporarily relieves the local itching and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas
temporarily relieves irritation and burning

Warnings

Warnings For external use only.

Otc - When Using

When using this product

do not use more than directed unless told to do so by a doctor
do not put directl in rectum by using fingersd or any mechanical device or applicator

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get mnedical help or contact a Poison Control Center right away.

Indications & Usage

Directions

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 externally to the affected area up to 6 times daily or after each bowel movement
after application, discard pad

Children under 12 years of age: ask a doctor