Label: RITE AID ROLL-ON- 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 August 9, 2018

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  • Drug Facts


  • Active Ingredients

    Menthol USP 4%

  • Purpose

    Cooling Pain Relief

  • Uses:

    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 skin 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, or if symptoms persist for more than 7 days, or clear up and reoccur

    If pregnant or breast-feeding:

    Ask a health professional before use

    Keep out of reach of children:

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

  • 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 physician

  • Inactive Ingredients:

    Aloe Vera gel, Camphor, Carbomer, FD&C blue 1, FD&C yellow 5 Glycerol, Isopropyl Alcohol, Ispropyl Myristate, Purified water, Silica, triethanolamine, Tocopheryl (Vitamin E) Acetate, 

  • Other Information:

    Store in a cool dry place with lid closed tightly

  • Questions or Comments

    1-855-314-1850

  • PRINCIPAL DISPLAY PANEL

    Untitled

  • INGREDIENTS AND APPEARANCE
    RITE AID ROLL-ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72351-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72351-008-0096 in 1 PACKAGE; Type 0: Not a Combination Product08/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/09/2018
    Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)
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