Label: SOLID ROOTS ROLL-ON RELIEF- menthol 3 percent liquid

  • NDC Code(s): 76348-481-01
  • 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 June 13, 2022

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

View All Sections
  • ACTIVE INGREDIENT

    Menthol 3 percent

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    Uses

    for temporary relief of minor aches and pains of muscles and joints associated with

    • bruises
    • sprains
    • arthritis
    • strains
  • 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

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

  • DOSAGE & ADMINISTRATION

    Adults and children twelve years of age and older,

    apply to affected area no more than ten times a day as needed for pain

    children under twelve years of age do not use, consult a doctor

  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Menth Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Hamamelis Virginiana (Witch Hazel)

  • QUESTIONS

    Questions? Comments ?

    HELLO@AUTHENTICBLENDS.COM

    AUTHENTIC BLENDS, LLC

    HAVERTOWN, PA 19083

  • PRODUCT MULTI-LAYER LABEL Page 1 of 3 Page 2 of 3 Page 3 of 3

    LABEL PG 2 OF 3LABEL PG 1 OF 3

    LABEL PG 3 OF 3_END

    LABEL IS A MULTI-LAYER. PAGE 1, PAGE 2 AND PAGE 3 ALL PART OF THE PEEL BACK LABEL

  • INGREDIENTS AND APPEARANCE
    SOLID ROOTS ROLL-ON RELIEF 
    menthol 3 percent liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-481
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.84 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    GRAPEFRUIT (UNII: O82C39RR8C)  
    WATER (UNII: 059QF0KO0R)  
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    MAGNESIUM OROTATE (UNII: GI96W46M5A)  
    LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)  
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-481-0128 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/13/2022
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-481)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!