Label: PAIN RELIEVING- menthol gel

  • NDC Code(s): 61010-4403-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol USP 4%

  • Purpose

    Cooling Pain Relief

  • Use

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

  • Warnings

    • For external use only.

    Flammable:Keep away from excessive heat or open flame.

    Ask a doctor before use if you have:sensitive skin.

    When using this product:

    • Avoid contact with eyes or mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not use with other ointments, creams, sprays or liniments
    • Do not apply to irritated skin or if excessive irritation develops
    • Do not bandage
    • Wash hands after use with cool water
    • Do not use with heating pad or device

    Stop use and ask a doctor if:

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days.

    If pregnant or breast feeding: Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
    • Children under 2 years of age:Consult a physician
  • Other Information

    Store in a cool dry place.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leal), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, TocopheryI Acetate, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 4 oz Pain Relieving Gel

    Safetec®

    Pain Relieving Gel

    For Minor Aches & Pains of Muscles & Joints

    Net Wt. 4 oz. (113.4g)

    Reorder No. 58002

    Manufactured for: Safetec of America, Inc.

    Buffalo, NY 14215 I 1-800-456-7077

    Made in IndiaKD/739

    Principal Display Panel – 4 oz Pain Relieving Gel
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHYLAMINE (UNII: VOU728O6AY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4403-1113.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-4403)
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!