Label: STAPHWASH PLUS- zinc acetate liquid

  • Category: HUMAN OTC DRUG LABEL

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 August 23, 2010

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  • DRUG FACTS

    Drug Facts
    Active Ingredients                            Purpose
    Zinc acetate (.1% by volume)           Skin Protectant
    ________________________________________
    Uses
    Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces
    ________________________________________
    Warnings
    For external use only   
    Keep away from children   
    Avoid contact with eyes  
    May be harmful if swallowed or inhaled
    ________________________________________
    Ask a doctor
    If symptoms last for more than 7 days or clear up and recur within a few days.
    If the conditions do not improve.  
    Before use on children under 2 years.
    Before use if you are allergic to any ingredients listed on this label.
    ________________________________________
    Directions
    Apply to affected skin area and rub gently.  Repeat the process as needed.
    ________________________________________
    Other information  
    StaphWash Plus is an OTC skin protectant drug product for human use.  Store at 40 to 120 degrees F.  Net contents:  3 mL (dropper bottle).  This product contains no alcohol; no animal products; no biological products.              
    ________________________________________
    Inactive ingredients 
    Water, color, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide,sodium dodecylbenzene sulfonate, ascorbic acid, magnesium stearate, silica and stearic acid.                       
    ________________________________________
    Questions and Side effects
    StaphWash Plus use results in no known side effects when used according to directions.  Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;    Tel.  580-746-2430  
    Email address:  PhillipsCompany@cox.net


  • ACTIVE INGREDIENTS

    Active Ingredients                            Purpose
    Zinc acetate (.1% by volume)           Skin Protectant

  • ASK DOCTOR

    Ask a doctor
    If symptoms last for more than 7 days or clear up and recur within a few days.
    If the conditions do not improve.  
    Before use on children under 2 years.
    Before use if you are allergic to any ingredients listed on this label.

  • DO NOT USE


    Warnings
    For external use only   
    Keep away from children   
    Avoid contact with eyes  
    May be harmful if swallowed or inhaled

  • CHILDREN

     
    Keep away from children   
    Avoid contact with eyes  
    May be harmful if swallowed or inhaled

  • PURPOSE


    Active Ingredients                            Purpose
    Zinc acetate (.1% by volume)           Skin Protectant

  • STOP USE


    If symptoms last for more than 7 days or clear up and recur within a few days.
    If the conditions do not improve.   
    Before use on children under 2 years.
    Before use if you are allergic to any ingredients listed on this label.
  • WHEN USING


    For external use only   
    Avoid contact with eyes  
    May be harmful if swallowed or inhaled
    If symptoms last for more than 7 days or clear up and recur within a few days.
    If the conditions do not improve.  
    Store at 40 to 120 degrees F.

  • WARNINGS



    Warnings
    For external use only   
    Keep away from children   
    Avoid contact with eyes  
    May be harmful if swallowed or inhaled
    StaphWash Plus use results in no known side effects when used according to directions. 

    Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;    Tel.  580-746-2430  
    Email address:  PhillipsCompany@cox.net

  • DOSAGE & ADMINISTRATION

    Uses
    Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces

    Directions
    Apply to affected skin area and rub gently.  Repeat the process as needed.

  • USE

    Uses
    Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli and may help provide relief to such surfaces

    Apply to affected skin area and rub gently.  Repeat the process as needed.

  • INACTIVE INGREDIENTS

    Inactive ingredients
    Water, color, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide,sodium dodecylbenzene sulfonate, dimethyl sulfoxide, witch hazel, ascorbic acid, magnesium stearate, silica and stearic acid. 

  • Image of product

    Image of product

    Image of product

  • INGREDIENTS AND APPEARANCE
    STAPHWASH PLUS 
    zinc acetate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc0.001 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    dipropylene glycol (UNII: E107L85C40)  
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    chlorhexidine gluconate (UNII: MOR84MUD8E)  
    calcium gluconate (UNII: SQE6VB453K)  
    methylparaben (UNII: A2I8C7HI9T)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sorbic acid (UNII: X045WJ989B)  
    magnesium stearate (UNII: 70097M6I30)  
    stearic acid (UNII: 4ELV7Z65AP)  
    witch hazel (UNII: 101I4J0U34)  
    sodium dodecylbenzenesulfonate (UNII: 554127163Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43074-105-021 in 1 BOTTLE, PLASTIC
    1NDC:43074-105-013 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/23/2010
    Labeler - Phillips Company (612368238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phillips Company612368238manufacture