Label: SPARKLING MIST ANTIBACTERIAL CLEANSER WITH MOISTURIZERS- triclosan lotion

  • 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 July 15, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    TRICLOSAN 0.15% (ANTIBACTERIAL)

  • USES AND DIRECTIONS

    • USES: FOR WASHING TO DECREASE BACTERIA ON THE SKIN.
    • DIRECTIONS: SQUEEZE ONTO WET HANDS OR BODY SPONGE, WORK INTO A LATHER, WASH SKIN, RINSE AND DRY THOROUGHLY
  • WARNINGS

    • FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    • IRRITATION AND REDNESS DEVELOPS.

    KEEP OUT OF REACH OF CHILDREN

    • IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
  • PACKAGE FRONT AND BACK LABELS

    24OZ FRONT AND BACK LABELS: mmark24.jpg24OZ FRONT AND BACK LABELS

  • INGREDIENTS AND APPEARANCE
    SPARKLING MIST  ANTIBACTERIAL CLEANSER WITH MOISTURIZERS
    triclosan lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-804-24710 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/15/2010
    Labeler - Apollo Health and Beauty Care (201901209)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!