Label: RITE AID HOT AND COLD PAIN RELIEF PAIN RELIEVING- lidocaine hcl and menthol cream

  • 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, 2022

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  • SPL UNCLASSIFIED SECTION

    Rite Aid Lidocaine-Menthol Pain Relief Cream

  • Active Ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • Purposes

    Topical anesthetic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

    Avoid contact with eyes

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • Use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contact with eyes

    • do not bandage or apply local heat (such as heating pads) to the area of use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for 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 and pets.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    adults and children over 12 years:

    • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    RITE AID HOT AND COLD PAIN RELIEF  PAIN RELIEVING
    lidocaine hcl and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-4216-11 in 1 CARTON06/01/2022
    176.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2022
    Labeler - Rite Aid (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(11822-4216)
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