Label: LACTIGO- menthol gel

  • 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 June 3, 2021

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  • Active ingredient

    Menthol 1.25%

  • Purpose

    Topical analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints.

  • Warnings

    For external use only.

    • Avoid contact with eyes and mucous membranes.
    • If contention worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this 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

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: Consult a doctor.

  • Other information

    Store at 15°C to 30°C (59°F to 86°F).

  • Inactive ingredients

    Ethoxydiglycol, glycerine, L-carnosine, magnesium sulfate, phenoxyethanol, water, xanthan gum

  • Questions?

    1-844-522-8446

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LACTIGO 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72481-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    WATER (UNII: 059QF0KO0R)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (White to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72481-101-03100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/21/2019
    Labeler - LactiGo, Inc. (116992874)
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