Label: SUGARLOAF ORGANICS MENTHOL REVIVE- menthol cream

  • NDC Code(s): 76348-996-01, 76348-996-04
  • 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 April 25, 2023

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  • ACTIVE INGREDIENT

    Menthol 5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains associated with

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • WARNINGS

    For external use only

  • WHEN USING

    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

    Instructions: Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.

  • INACTIVE INGREDIENT

    Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, with a proprietary blend of terpenes (alpha-bisabolol,

    alpha-humulene, beta-caryophyllene, caryophyllene oxide, gualol, linalool),

    Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Fragrance, Hemp-derived Cannabichromene (CBC), Cannabidiol (CBD), and Cannabigerol (CBG),

    Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter,

    Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid

  • QUESTIONS

    Sugarloaf Organics

    Drums, PA 18222

    P: 570.866.5882

    www.sugarloaforganic.com

  • PRINCIPAL DISPLAY PANEL

    Sugarloaf Organics Revive Menthol Pain Cream

    Label and Box

    Sugarloaf Boxsugarloaf label

  • INGREDIENTS AND APPEARANCE
    SUGARLOAF ORGANICS MENTHOL REVIVE 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.9 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIGEROL (UNII: J1K406072N)  
    CANNABICHROMENE (UNII: K4497H250W)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CORN OIL (UNII: 8470G57WFM)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-996-011 in 1 BOX04/25/2023
    1NDC:76348-996-04118 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/25/2023
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-996)
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