Label: BIOFREEZE - menthol gel

  • NDC Code(s): 59316-101-10, 59316-101-11, 59316-101-12, 59316-101-13, view more
    59316-101-15, 59316-101-20, 59316-101-21, 59316-101-25, 59316-101-30, 59316-101-40, 59316-101-50
  • Packager: Performance Health LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/14

If you are a consumer or patient please visit this version.

  • Biofreeze
  • Active Ingredients

    Natural Menthol USP 3.5%

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  • Purpose

    Cooling Pain Reliever

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  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain

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  • Warnings:

    For external use only.

    Flammable:

    Keep away from excessive heat or open flame

    Ask a doctor before use if you have:

    sensitive skin

    • Avoid contact with the eyes or mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not use with other ointments, creams, sprays or liniments
    • Do not apply to irritated skin or if excessive irritation develops
    • Do not bandage
    • Wash hands after use with cool water
    • Do not use with heating pad or device

    Stop Use And Ask A Doctor If:

    Condition worsens, or of symptoms persist for more than 7 days, or clear up and reoccur.

    If pregnant or breastfeeding:

    Ask a health professional before use.

    Keep out of the reach of children:

    If accidentally ingested, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
    • Children under 2 years of age : Consult physician
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  • Other Information:

    Store in a cool dry place with lid closed tightly

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  • INACTIVE INGREDIENT

    • carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water U
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  • Questions or Comments?

    1-330-633-8460

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  • Representative Labeling
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE  
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59316-101
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (Menthol) Menthol 35 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    GLYCERIN  
    ISOPROPYL ALCOHOL  
    METHYLPARABEN  
    CAMPHOR (NATURAL)  
    PROPYLENE GLYCOL  
    SILICON DIOXIDE  
    TROLAMINE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59316-101-10 5 mL in 1 PACKET
    2 NDC:59316-101-15 89 mL in 1 BOTTLE, WITH APPLICATOR
    3 NDC:59316-101-20 118 mL in 1 TUBE
    4 NDC:59316-101-21 81 mL in 1 TUBE
    5 NDC:59316-101-30 473 mL in 1 BOTTLE, PUMP
    6 NDC:59316-101-40 946 mL in 1 BOTTLE, PUMP
    7 NDC:59316-101-50 3785 mL in 1 BOTTLE, PUMP
    8 NDC:59316-101-25 118 mL in 1 TUBE, WITH APPLICATOR
    9 NDC:59316-101-12 59 mL in 1 TUBE
    10 NDC:59316-101-13 59 mL in 1 BOTTLE, WITH APPLICATOR
    11 NDC:59316-101-11 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/03/2010
    Labeler - Performance Health LLC. (794324061)
    Establishment
    Name Address ID/FEI Business Operations
    Span Packaging Services LLC 557434805 manufacture(59316-101)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmetic Essence,LLC 825646862 manufacture(59316-101)
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