Label: UDDER ESSENCE BETTER BALM MEDICATED- menthol and methyl salicylate cream

  • NDC Code(s): 24465-879-03, 24465-879-04, 24465-879-16
  • Packager: LC&G Distributing Inc.
  • 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 September 19, 2012

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

View All Sections
  • PURPOSE

    Medicated Better Balm is a topical aid for irritation from minor cuts, scrapes, scratches, and chapping.

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN

    Avoid contact with eyes.

    For External use only.

    Discontinue use if irritation occurs.

    Not to be applied to deep or puncture wounds.

  • Directions

    Apply liberally to clean exposed areas. Repeat as necessary.

  • Ingredients

    Water, Mineral Oil, Glycerin, Cetearyl Alcohol, Stearic Acid, Propylene Glycol, Sorbitol, Glycol Stearate, Potassium Hydroxide, Lanolin, Methyl Paraben, Propyl Paraben, Menthol, Methyl Salicylate, Tocopherol Acetate (Vitamin E), Aloe Vera Gel, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D), FD&C Blue #1.

  • Questions or Comments?

    PO Box 6874, Spring Hill, FL 34611

  • PRINCIPAL DISPLAY PANEL - 454 Gram Jar

    Vitamins
    A, D and E
    Aloe Vera Gel
    Lanolin

    Udder Essence

    BETTER BALM
    Medicated

    Net Weight
    16oz. (1LB.)
    (454 grams)

    Principal Display Panel - 454 Gram Jar
  • INGREDIENTS AND APPEARANCE
    UDDER ESSENCE BETTER BALM MEDICATED 
    menthol and methyl salicylate cream
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:24465-879
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol0.25 g  in 100 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitol (UNII: 506T60A25R)  
    Glycol Stearate (UNII: 0324G66D0E)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Lanolin (UNII: 7EV65EAW6H)  
    Methylparaben Sodium (UNII: CR6K9C2NHK)  
    Propylparaben Sodium (UNII: 625NNB0G9N)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Vitamin A (UNII: 81G40H8B0T)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24465-879-16454 g in 1 JAR
    2NDC:24465-879-0385 g in 1 TUBE
    3NDC:24465-879-041816 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved Drug Other03/01/2011
    Labeler - LC&G Distributing Inc. (795315436)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Pharmaceuticals Inc.617660712MANUFACTURE, API MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

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