Label: BIOCHEMISTRY PAIN RELIEF FOOT ACTIVE- benzyl alcohol, lidocaine hydrochloride liquid

  • NDC Code(s): 65121-209-31, 65121-209-32
  • Packager: Pure Source, LLC
  • 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 February 10, 2017

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  • biochemistry PAIN RELIEF FOOT SPRAY ACTIVE
  • Active ingredients

    Benzyl Alcohol 19%
    Lidocaline HCL 4%

    Purpose

    Topical Anesthetic

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  • Uses

    • For temporary relief of minor foot pain.
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  • Warnings

    For external use only

    Avoid contact with eyes

    • Do not apply to open wounds or damaged skin
    • If pain persists consult a physician. If conditions worsens, or if symptoms persist for more than seven days, or if conditions clear up and occur again within a few days, discontinue use of this product and consult a physician

    Do not use

    in large quantities over raw surfaces or blistered areas

    Consult your doctor

    if any adverse effect or allergy develops

    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
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  • Directions

    • Over 12-years
    • Apply directly to affected area
    • Do not wrap affected area
    • Do not use more than four times per day
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  • Other information

    • Store between 58 o - 87 o F
    • Protect from freezing, direct hear or sunlight.
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  • Inactive ingredients

    Aqua (Deionized Water), Dimethyl Sulfone (MSM), Glycyrrhiza Glabra (Licorice) Extract, Potassium Sorbate, Peppermint Oil, Propylene Glycol, SD-Alcohol 40B, Tea Tree Oil

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  • biochemistry PAIN RELIEF FOOT SPRAY ACTIVE 30ml (65121-209-31) | biochemistry PAIN RELIEF FOOT SPRAY ACTIVE 60ml (65121-209-32)
  • INGREDIENTS AND APPEARANCE
    BIOCHEMISTRY PAIN RELIEF FOOT ACTIVE 
    benzyl alcohol, lidocaine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-209
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 190 mg  in 1 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65121-209-31 1 in 1 CARTON 02/09/2017
    1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2 NDC:65121-209-32 1 in 1 CARTON 02/09/2017
    2 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/06/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source, LLC 080354456 manufacture(65121-209) , repack(65121-209) , relabel(65121-209)
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