Label: DOLORAN- menthol, camphor, methyl salicylate ointment

  • 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 December 27, 2019

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

View All Sections
  • Active Ingredients

    Active Ingredients Purpose

    Menthol _______________________________ 2.0% Topical Analgesic

    Camphor ______________________________ 8.0% Topical Analgesic

    Methyl Salicylate_________________________ 8.0% Topical Analgesic

  • Purpose

    Topical Analgesic

  • Use

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    • Do not use​ on wounds or damaged skin with a healing pad
    • Do not use on a child under 12 years of age with arthritis-like conditions

    Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of htis product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Use only as directed
    • Adults and children 12 years of age and older; apply to affected area not ore than 3 to 4 times daily
    • Children under 12 years of age; ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients (Petrolatum, anhydrous lanolin, parrafin)

  • PRINCIPAL DISPLAY PANEL

    PDP.jpg

  • INGREDIENTS AND APPEARANCE
    DOLORAN 
    menthol, camphor, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71016-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.08 g  in 1 g
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-0.08 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color    Score    
    ShapeROUNDSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71016-001-201 in 1 BOX10/24/2016
    120 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/24/2016
    Labeler - Hector Rivera Garzon y Compania. S. en C. (881238799)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

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