Label: 1ST RELIEF TOPICAL- lidocaine and menthol spray

  • NDC Code(s): 69094-226-04
  • Packager: 1st Class Pharmaceuticals, Inc.
  • 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 December 28, 2017

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  • ACTIVE INGREDIENT:

    Lidocaine 4.00%

    Menthol 1.00%

  • PURPOSE

    Topical Analgesic

    Topical Analgesic

  • Indications:

    For temporary relieft of pain associated with minor burns, minor cuts, scrapes, insect bites or skin irritations.

  • Warnings:

    • For external use only
    • Avoid contact with eyes
    • Do not apply to open wounds or damages skin.
  • STOP USE

    • If symptoms persist for more than seven days, discontinue use and consult physician.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, conslut physician.

  • Directions

    • Apply directly to affected area. Do not use more than four times per day. Children under two-years of age: consult a physician.
  • Other Ingredients:

    Aqua (Deionized Water), ARNICA MONTANA,BOSWELLIA SERRATA, CETYL MYRISTOLEATE, EMU OIL, GLYCYRRHIZA GLABRA, METHYLSULFONYLMETHANE (MSM), POLYSORBATE 20, POTASSIUM SORBATE, SD-Alcohol 40B, SODIUM BENZOATE

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, contact physician prior to use.

  • Package Label

    NDC 69094-226-04

    1st Class

    PHARMACEUTICALS INC.

    1st RELIEF

    TOPICAL SPRAY

    For temporary relief of:

     • backache • bruises • arthritis • sprains

    4 Fl OZ. (118 ml)

    Distributed by:

    1st Class PHARMACEUTICALS INC.

    Los Angeles, CA 90064

    www.1stclass pharmaceuticals.com

    Label

  • INGREDIENTS AND APPEARANCE
    1ST RELIEF TOPICAL 
    lidocaine and menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69094-226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    EMU OIL (UNII: 344821WD61)  
    GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69094-226-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/02/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/02/2014
    Labeler - 1st Class Pharmaceuticals, Inc. (079448685)
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