1ST RELIEF TOPICAL (LIDOCAINE AND MENTHOL) SPRAY [1ST CLASS PHARMACEUTICALS, INC.]

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1ST RELIEF TOPICAL (LIDOCAINE AND MENTHOL) SPRAY [1ST CLASS PHARMACEUTICALS, INC.]
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NDC 69094-226-04
Set ID e82e1df8-d722-4acf-b907-f8f50b242710
Category HUMAN OTC DRUG LABEL
Packager 1st Class Pharmaceuticals, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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