Label: ELP ESSENTIAL MANTECA DE UBRE- methyl salicylate, camphor ointment

  • NDC Code(s): 79974-210-04
  • Packager: Miramar Cosmetics, Inc DBA Miramar Lab
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • Drug Facts

  • Active Ingredient

    Methyl Salicylate 10%

    Camphor 4%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

  • Warnings

    For external use only • Avoid contact with eyes • Avoid mucous membranes

    Do Not Use
    In open wounds or damaged skin, with a heating pad, or with a tight bandage.

    Stop use and Ask the doctor if.
    You are allergic to Salicylate or any of this product's inactive ingredients, symptoms persist for more than seven days, redness is present or excessive irritation on the skin develops.

    If pregnant or breast feeding. Contact a physician before use.

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

  • Directions

    Wash the area with mild soap and warm water, rinse thoroughly. Apply generously and gently massage the affected area not more than 1 to 4 times daily. For Adults and Children 12 years of age and older. Children under 12 years of age or younger, ask a doctor.

  • Other Information

    Tamper Evident Feature Do not use if seal under cap is torn, broken or missing. Store at 15° to 25° C (59° to 77° F)

  • Inactive Ingredients

    Snow White Petrolatum, Tea Tree Oil, Eucalyptus Oil, Menthol, D&C Yellow.

  • Questions or Comments?

    Call 786 6469178 Weekdays from 9:30 Am to 4:30 Pm Eastern time.

  • SPL UNCLASSIFIED SECTION

    UDDER BALM

    EXTRA STRENGTH FORMULA

    ANALGESIC OINTMENT

    Distributed by essential products Miami, FL, 33012

    Made In U.S.A.

    Essentialproductsusa.com

  • Packaging

    Udderbalm1

  • INGREDIENTS AND APPEARANCE
    ELP ESSENTIAL MANTECA DE UBRE 
    methyl salicylate, camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79974-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79974-210-04113 g in 1 TUBE; Type 0: Not a Combination Product01/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/05/2024
    Labeler - Miramar Cosmetics, Inc DBA Miramar Lab (012873243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miramar Cosmetics, Inc DBA Miramar Lab012873243manufacture(79974-210)
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