Label: RITE AID LIDOCAINE ROLL ON- lidocaine hydrochloride liquid

  • 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 October 5, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical anesthetic

  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only

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

    Flammable

    • keep away from fire or flame

    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 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 gel, cetyl alcohol, dimethicone, disodium EDTA, ethylhexylglycerin, C10-30 alkyl acrylate cross polymer, polysorbate 60, glycerin, triethanolamine, water, stearyl alcohol.

    Child-resistant packaging. Close cap tightly after use. Keep carton as it contains important information.

  • Principal Display Panel

    1Pain-relieving-roll-on_2.5-floz

  • INGREDIENTS AND APPEARANCE
    RITE AID LIDOCAINE ROLL ON 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-307-471 in 1 CARTON03/01/2017
    173 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2017
    Labeler - Velocity Pharma LLC (962198409)
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