Label: ASPERCREME WITH LIDOCAINE DRY- lidocaine spray

  • 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 9, 2021

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  • SPL UNCLASSIFIED SECTION

    ASPERCREME with LIDOCAINE  SPRAY

    Drug Facts

  • Active ingredient

  • Purpose

    Lidocaine 4%..................................................................................................................................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 label. 

    ■ do not allow contact with the eyes and mucous membranes

    ■ avoid spraying on face

    ■ avoid inhalation of spray

    ■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

    ■ do not use at the same time as other topical analgesics

    Stop use and ask a doctor if

    ■ condition worsens

    ■ redness is present

    ■ irritation develops

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

    Extremely Flammable

    ■ do not use near heat or flame or while smoking

    ■ avoid long term storage above 104°F (40°C)

    ■ do not puncture or incinerate. Contents under pressure.

    ■ do not store at temperatures above 120°F (49°C)

    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 right away.

  • Directions

    adults and children over 12 years:

    ■ spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

    ■ product will dry quickly on its own, and does not need to be rubbed in

    children 12 years or younger: ask a doctor

  • Inactive ingredients:

    alcohol denat. (30%), caprylic/capric triglyceride, isobutane, propylene glycol

  • PRINCIPAL DISPLAY PANEL

    MAX STRENGTH
    Aspercreme 
    LIDOCAINE
    PAIN RELIEF SPRAY
    NET WT 4 OZ (113 g)

    MAX STRENGTH Aspercreme LIDOCAINE PAIN RELIEF SPRAY NET WT 4 OZ (113 g)

  • INGREDIENTS AND APPEARANCE
    ASPERCREME WITH LIDOCAINE DRY 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0583-5113 mL in 1 CAN; Type 0: Not a Combination Product01/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/02/2019
    Labeler - Chattem, Inc. (003336013)
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