Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules
FDA Label NDC 43553-0000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Convatec Inc for the product Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules (NDC 43553-0000). 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 (in each 20ml), purpose, uses, warnings, directions, other information, inactive ingredient:, package labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each 20Ml)

Poloxamer 188 (20%)

Purpose

Skin Wound Cleanser

Uses

• Aids in the removal of foreign materials such as dirt and debris
• To clean superficial wounds

Warnings

• For external use only • This product is not for use on wild or domestic animal bites. If you have an animal bite, consult your physician immediately • Do not use this product for more than 10 days. If condition worsens or persists, see your physician • Do not bandage tightly

Directions

• Twist off sealed tab
• Apply contents directly to the area to be cleansed
• Contents may be poured onto an Optipore® Wound Cleansing Sponge or sterile gauze pad, then gently cleanse

Other Information

• Do not use if sealed tab is broken or missing
• Not for injection
• This product contains no antimicrobial ingredients

Inactive Ingredient:

Purified Water

Package Labeling:

Label (Label)

Label (Label)

* Please review the disclaimer below.