Label: BAE SCIENCES MENTHOL MUSCLE RUB- menthol muscle rub lotion

  • NDC Code(s): 76348-505-01, 76348-505-02
  • Packager: Renu Laboratories, 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 August 18, 2023

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  • ACTIVE INGREDIENT

    Menthol USP 5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: for temporary relief of minor aches and pains of muscles and joints associated with deep-muscle therapy treatments.

  • WARNINGS

    For external use only

  • WHEN USING

    When using this product:

    Do not bandage tightly

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not use with heating pads or other heating devices.
  • STOP USE

    Stop use and ask a doctor if

    Condition worsens or if symptoms persist for more than 7 days or

    clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your health care provider.
    • children under 12 years of age, consult your health care provider.
  • STATEMENT OF IDENTITY

    Bae Sciences Menthol Muscle Rub

  • QUESTIONS

    Manufactured for Bae Sciences

    Miami, FL 33132

    ph. 754-227-9222

    Baesciences.com

  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoalkane, Cannabidiol, Cannabigerol, Cannabis Sativa (Hemp) Seed Oil, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, PEG-100 Stearate, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Oil, Niacinamide, Olea Europaea (Olive) Fruit Oil, Olus (Vegetable) Oil, Polyacrylamide, Stearic Acid and a proprietary blend of terpenes, including alpha-bisabolol, alpha-humulene, alpha-pinene, alpha-terpinene, beta-caryophyllene, beta-myrcene, beta-pinene, caryophyllene oxide, cis-beta-ocimene, D-limonene, eucalyptol, gamma-terpinene, guaiol, linalool, menthol, p-cymene, terpinolene, trans-nerolidiol

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL ART AND PRODUCT BOX ART

    Bae Box Art

    Bae Product Label

  • INGREDIENTS AND APPEARANCE
    BAE SCIENCES MENTHOL MUSCLE RUB 
    menthol muscle rub lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 95 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    NEROLIDOL (UNII: QR6IP857S6)  
    MYRCENE (UNII: 3M39CZS25B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    P-CYMENE (UNII: 1G1C8T1N7Q)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    .BETA.-PINENE (UNII: 4MS8VHZ1HJ)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    .GAMMA.-TERPINENE (UNII: 4YGF4PQP49)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIGEROL (UNII: J1K406072N)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    HUMULENE (UNII: 54W56MD2WD)  
    .ALPHA.-PINENE (UNII: JPF3YI7O34)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CORN OIL (UNII: 8470G57WFM)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    .BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)  
    TERPINOLENE (UNII: N9830X5KSL)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GUAIOL (UNII: I7WP008A91)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-505-021 in 1 BOX08/21/2023
    1NDC:76348-505-0195 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/21/2023
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-505)
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