Label: RITE AID COOL THERAPY GEL- 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 May 26, 2022

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  • Drug Facts

  • Active Ingredients

    Menthol 4%

    Purpose

    Topical Analgesic

  • 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 the 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 irritated develops; Do not bandage; Wash hands after use with cool water; Do not use with a 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 swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 physician

  • Inactive Ingredients

    benzyl alcohol, butylated hydroxy tolune, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue No.1, FD&C Yellow No. 5, Isopropyl Alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, Water

  • Questions or Comments

    1-866-326-1313 Monday- Friday 8:30am-4:30 pm CST

  • Package Labeling:

    label

  • INGREDIENTS AND APPEARANCE
    RITE AID COOL THERAPY GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-4217-188.72 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2022
    Labeler - Rite Aid (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(11822-4217)
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