Label: SHUR CLENS SKIN WOUND CLEANSER 24 COUNT SINGLE DOSE AMPULES- poloxamer 188 liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2021

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  • Drug Facts

  • 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

    Keep out of reach of children

  • 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

  • INGREDIENTS AND APPEARANCE
    SHUR CLENS SKIN WOUND CLEANSER 24 COUNT SINGLE DOSE AMPULES 
    poloxamer 188 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43553-0000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLOXAMER 188 (UNII: LQA7B6G8JG) (POLOXAMER 188 - UNII:LQA7B6G8JG) POLOXAMER 188200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43553-0000-024 in 1 CARTON10/26/2017
    120 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/26/2017
    Labeler - ConvaTec Inc (080128290)
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