Label: ALL-NATURAL PEN SPRAY- silver citrate aerosol, spray

  • 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 February 3, 2010

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  • Active Ingredient

    Active Ingredient: Citric Acid and Silver Citrate     0.3%

  • Purpose

    Purpose:  Antiseptic

  • Uses

    Uses: To decrease bacteria on the skin that can cause disease. Recommend for repeated use.

  • Warnings

    Warnings: For external use on hands only. Not recommended for infants.

  • Directions

    Directions: Wet hands thoroughly with product and allow to dry without wiping. For children under 6, adult supervision required.

  • Inactive Ingredients

    Water (aqua), Aloe Barbadensis Extract, Ginger (Zinginber Officinale) Extract, Witch Hazel (Hamamelis Virginiana) Extract, Sweet Almond (Prunus Amygdalus Dulcis) Extract

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    ALL-NATURAL PEN SPRAY 
    silver citrate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50538-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER CITRATE (UNII: CKA421A1J7) (SILVER CATION - UNII:57N7B0K90A) SILVER CITRATE0.15 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 91.7 g  in 100 g
    GINGER (UNII: C5529G5JPQ) 1 g  in 100 g
    WITCH HAZEL (UNII: 101I4J0U34) 1 g  in 100 g
    ALMOND (UNII: 3Z252A2K9G) 3 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50538-001-0110 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33302/09/2010
    Labeler - HANGZHOU KARIC COMMODITIES CO., LTD. (526884335)
    Registrant - HANGZHOU KARIC COMMODITIES CO., LTD. (526884335)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU KARIC COMMODITIES CO., LTD.526884335manufacture