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

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 August 26, 2016

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

  • Active Ingredients

    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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  • BIOFREEZE - menthol gel (59316-101-10)
  • BIOFREEZE - menthol gel (59316-101-11)
  • BIOFREEZE - menthol gel (59316-101-13)
  • BIOFREEZE - menthol gel (59316-101-12)
  • BIOFREEZE - menthol gel (59316-101-15)
  • BIOFREEZE - menthol gel (59316-101-20)
  • BIOFREEZE - menthol gel (59316-101-30)
  • BIOFREEZE - menthol gel (59316-101-50)
  • BIOFREEZE - menthol gel (59316-101-40)
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59316-101-10 5 mL in 1 PACKET; Type 0: Not a Combination Product 08/25/2016
    2 NDC:59316-101-15 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/25/2016
    3 NDC:59316-101-20 118 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2016
    4 NDC:59316-101-21 81 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2016
    5 NDC:59316-101-30 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2016
    6 NDC:59316-101-40 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2016
    7 NDC:59316-101-50 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2016
    8 NDC:59316-101-25 118 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 08/25/2016
    9 NDC:59316-101-12 59 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2016
    10 NDC:59316-101-13 59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/25/2016
    11 NDC:59316-101-11 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/25/2016
    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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