Label: TOPICAL ANALGESIC- dermaline 3 in 1 roll on emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 26, 2022

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  • ACTIVE INGREDIENT

    LabelMethyl Salicylate 15%

  • PURPOSE

    Topical Analgesic

  • INSTRUCTIONS FOR USE

    Uses: For temporary relief of minor aches and pains of muscles and joints, such as simple backahe, lumbago, arthritis, neuralgia, strains, bruises, and sprains

  • WARNINGS

    Warning: External use only. Keep out of reach of children. Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

  • DO NOT USE

    Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.

  • INDICATIONS & USAGE

    Directions: Adult and children 16 years and older. Wash affected area with mild soap and warm water and rinse throughly. Apply a small amount of Dermaline Arnica Ointment to the affected area 1 to 3 times daily.

  • INACTIVE INGREDIENT

    Camphor, Capsicum Extract, Carbomer, Deionized Water, DMDM hydantoin, Eucalyptus Oil, Isopropyl Alcohol, Menthol, Polysorbate 20, Propyleneglycol, Tocopherol Acetate, Triethanolamine, Tea Tree Oil

  • OTHER SAFETY INFORMATION

    Store at room temperature. 15 - 30 degrees C (59-86 degrees F). Avoid excessive heat & humidity

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions: Adult and children 16 years and older. Wash affected area with mild soap and warm water and rinse throughly. Apply a small amount of Dermaline Arnica Ointment to the affected area 1 to 3 times daily.

  • PRINCIPAL DISPLAY PANEL

    Arnica Roll On Label

  • INGREDIENTS AND APPEARANCE
    TOPICAL ANALGESIC 
    dermaline 3 in 1 roll on emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIETHANOLAMINE MYRISTATE (UNII: 68B0CQC306)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPSICUM OLEORESIN (UNII: UW86K581WY)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82165-107-0385.05 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2022
    Labeler - Dermaline USA Corp (016069241)
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