Label: PROTECT ANTIBACTERIAL BAR- triclosan soap

  • 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 April 26, 2020

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

  • SPL UNCLASSIFIED SECTION

  • Active Ingredient(s)

    Triclosan 0.3%

  • Purpose

    Antiseptic

  • Use

    Decrease bacteria on the skin

  • Warnings

    For external use only.

  • STOP USE

    Stop use and ask a doctor if redness or irritation develops and persist for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to skin while bathing or washing

    Rinse and repeat

  • Inactive ingredients

    Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Fragrance, Sodium Chloride, Disodium EDTA, CI 19140, CI 42090, CI 14700, CI 17200

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    PROTECT ANTIBACTERIAL BAR 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73885-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73885-002-01140 g in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2020
    Labeler - Boya Biotechnology Company Limited (403701144)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boya Biotechnology Company Limited403701144manufacture(73885-002)