Label: MF PRO KIT- chlorhexidine gluconate, zinc oxide kit

  • NDC Code(s): 43258-406-10
  • Packager: CARR & DAY & MARTIN INTERNATIONAL LTD
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 26, 2014

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

  • DRUG FACTS - MF PRO KIT

    Kit information is followed by Drug Facts for the kit contents and related products.

  • CONTENTS

    • Full & comprehensive instruction booklet
    • Antibacterial Cleanser (250ml)
    • Sterile Horse Care Sponge
    • Soothing antibacterial and antifungal balm (180g)
    • Professional Leg Wrap (150mtrs)
    • Protective Salve Barrier (500g)
  • QUESTIONS

    Refer to individual product labeling for detailed instructions.

  • DRUG FACTS - MF PRO ANTI-BACTERIAL CLEANSER (250 mL)

    ACTIVE INGREDIENTS

    Chlorhexidine Gluconate 2.0%

    Tea Tree Oil 0.2%

    Aloe Vera Extract 0.2%

    PURPOSE

    This specifically formulated cleanser is both gentle but extremely effective.

    Whilst containing powerful antibacterial agents it is also pH neutral which makes it particularly kind to skin.

    Essential oils and herbal extracts help quicken the process by soothing and calming irritated, sore, damaged or sensitive skin.

    DIRECTIONS FOR USE

    Dampen the affected area using warm water.

    Apply Cleanser directly to the skin and gently massage in using sponge.

    Leave in contact with the skin for 5 minutes to allow antibacterial cleansing and softening of scabs.

    Rinse with warm water and very gently remove any loose scabs from the skin.

    Gently remove excess moisture, allow the area to fully dry and continue on to Step 2.

  • DRUG FACTS - MF PRO SOOTHING BALM (180 g)

    ACTIVE INGREDIENTS

    Zinc Oxide 5.0%

    Tea Tree Oil 2.0%

    Keep out of reach of children.

    STORAGE

    Keep out of reach of children.

    Store in tightly closed original container.

    Store below 30°C.

    PURPOSE

    A concentrated, antifungal and antibacterial, moisturising balm, which effectively soothes and relieves, and protects irritated skin.

    This formulation contains some antiseptic properties and essential oils which can help to promote healthy skin condition.

    Antibacterial agents and moisturising ingredients can gently but efficiently calm skin complaints.

    Allows the skin to breathe freely and heal correctly in beneficial moist conditions.

    DIRECTIONS FOR USE

    Following on from Step 1 - ensure that the affected area is clean and dry.

    Apply this balm liberally by hand.

    Gently massage the balm into the skin and ensure that the entire affected area is covered.

    Next, apply the Leg Wrap as you would apply a bandage ensuring that the wrap is not too tight.

    (Whilst not essential - it is beneficial and can help speed up the process if a warm exercise bandage is applied over the top of the Leg Wrap).

    Leave overnight to allow full absorbtion.

  • DRUG FACTS - MF PRO PROTECTIVE SALVE BARRIER (500 g)

    ACTIVE INGREDIENTS

    Citronella Oil 1.5%

    PURPOSE

    A specifically formulated anti-bacterial salve containing natural mineral greases and citronella.

    It forms a waterproof barrier protecting skin from baterial infection brought on by skin invasive pathogens, which are present in wet and muddy conditions.

    This salve is also excellent for use on cuts, grazes or when an open wound, which cannot be stitched, requires protection.

    DIRECTIONS FOR USE

    First clean the affected area with Step 1.

    Allow the skin to dry, then apply liberally ensuring even coverage.

    (For best coverage apply in the direction of the hair, allow the body's natural heat to make the formula more pliable - then work well in to the skin to ensure that vulnerable areas are entirely covered.)

    Use daily, for turnout & riding, or as required.

    Ideally use as a preventative to avoid further or possible infection.

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MF PRO KIT

    Kit Carton

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MF PRO ANTI-BACTERIAL CLEANSER (250mL)

    Anti-Bacterial Cleanser Label

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MF PRO SOOTHING BALM (180 g)

    Soothing Balm Label

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MF PRO PROTECTIVE SALVE BARRIER (500 g)

    Protective Salve Barrier Label

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MF PRO EXCLUSIVE CLASSIC SPONGE

    Sponge Label

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MF PRO PROFESSIONAL LEG WRAP

    Leg Wrap Label

  • INGREDIENTS AND APPEARANCE
    MF PRO KIT 
    chlorhexidine gluconate, zinc oxide kit
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43258-406
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43258-406-101 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE .25 L
    Part 21 BOTTLE, DISPENSING .18 L
    Part 31 CANISTER .5 L
    Part 1 of 3
    MF PRO ANTI BACTERIAL CLEANSER 
    chlorhexidine gluconate, tea tree oil, aloe vera leaf shampoo
    Product Information
    Item Code (Source)NDC:43258-465
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorhexidine Gluconate (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) Chlorhexidine Gluconate20 g  in 1 L
    Tea Tree Oil (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) Tea Tree Oil2 g  in 1 L
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF2 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    OXATOMIDE (UNII: J31IL9Z2EE)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    ORIGANUM OIL (UNII: 39736Z7Q8W)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1.25 L in 1.0 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Part 2 of 3
    MF PRO SOOTHING BALM 
    zinc oxide, tea tree oil cream
    Product Information
    Item Code (Source)NDC:43258-460
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 g  in 1 L
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL20 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINAXOLONE (UNII: 737SKC73L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ISOTHIAZOLE (UNII: 38FAO14250)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1.18 L in 1.0 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Part 3 of 3
    MF PRO PROTECTIVE SALVE BARRIER  
    citronella oil cream
    Product Information
    Item Code (Source)NDC:43258-461
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRONELLA OIL (UNII: QYO8Q067D0) (CITRONELLA OIL - UNII:QYO8Q067D0) CITRONELLA OIL15 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    SOLVENT RED 27 (UNII: G7S71FND9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1.5 L in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2013
    Labeler - CARR & DAY & MARTIN INTERNATIONAL LTD (846964567)
    Registrant - CARR & DAY & MARTIN INTERNATIONAL LTD (846964567)
    Establishment
    NameAddressID/FEIBusiness Operations
    CARR & DAY & MARTIN INTERNATIONAL LTD846964567MANUFACTURE, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    The White Sea & Baltic Co Ltd236539933api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Elixens Uk Ltd210003356api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Peter Jarvis Cosmetic Developments Ltd290813328api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Brenntag Colours Ltd222088846api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Univar Ltd218315604api manufacture