Label: TRIPLE CARE PLUS ARNICA ANALGESIC - RECOVERY (methyl salicylate, camphor- synthetic, and menthol, unspecified form cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:  Purpose
    Methyl Salicylate 15%Topical analgesic
    Camphor 6%Topical analgesic
    Menthol 6%Topical analgesic
  • Uses

    Temporarily relieves the minor aches and pains of muscles & joints associated with:

    arthritis
    •
    sprains
    •
    general soreness
    •
    bruises
    •
    strains
  • Warnings

    For external use only.

    Avoid contact with eyes

    Do not use

    • On wounds or damaged skin
    • With heating pad
    • Do not bandage tightly

    Stop use and consult a doctor if condition worsens or if symptoms persist for more than 7 days.

    If pregnant or breast-feeding, consult a health professional before use.

    • This product may cause an allergic reaction for some individuals.

    Test on a small area before use.

    Keep out reach of children.

    If product is swallowed, seek medical help or contact a poison control center immediately.

  • Directions

    • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: consult a doctor.
  • Inactive Ingredients

    Water, Glyceryl Stearate SE, Butylene Glycol, Behenyl Alcohol, Stearic Acid, Polysorbate 80, Arnica Montana Flower Extract (Arnica 3%) Acrylates/C10-30, Alkyl Acrylate,Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Sodium Hydroxide

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Paloven, Inc., Englewood, NJ 07631

  • PRINCIPAL DISPLAY PANEL - 2.8 fl oz. Tube Label

    Triple Care +
    ARNICA

    Topical Analgesic - Recovery Cream

    made in USA
    2.8 fl oz.

    PRINCIPAL DISPLAY PANEL - 2.8 fl oz. Tube Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE CARE PLUS ARNICA   ANALGESIC - RECOVERY
    methyl salicylate, camphor (synthetic), and menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73128-614
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate12.42 g  in 82.8 g
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)4.968 g  in 82.8 g
    Menthol, Unspecified form (UNII: L7T10EIP3A) (Menthol, Unspecified form - UNII:L7T10EIP3A) Menthol, Unspecified form4.968 g  in 82.8 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Docosanol (UNII: 9G1OE216XY)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73128-614-2882.8 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2019
    Labeler - Paloven, Inc. (964795868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753MANUFACTURE(73128-614)
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