Label: ABEJAS Y VIBORAS BRAND ROLL-ON- menthol gel

  • 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 March 1, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthristis, strains and sprains.
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child 12 years of age and under
    • over extensive areas of the body
    • on irritated skin
    • with a bandage
    • with other ointments, creams, sprays or liniments

    Ask a doctor before use if you have redness over the affected area.

    When using this product

    • wash hands after use with cool water
    • avoid contact with eyes or mucous membranes
    • do not bandage

    Stop use and ask a doctor if

    • condition worsens or symptoms persists for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health profiessional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • use only as directed
    • Adults and children over 12 years: rub a thin film over affected areas not more than 4 times daily: message not necessary.
    • Children 12 years or younger: do not use. 
  • INACTIVE INGREDIENT

    Inactive ingredients Camphor, carbomer 940, D&C yellow #10, FD&C yellow #5, glycerin, isopropyl myristate, methyl salicylate, methylchloroisothiazolinone, methlylisothiazolinone, polysorbate 20, propylene glycol, triethanolamine, water.

  • QUESTIONS

    Questions? Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    AbjeasBox

    abejasbox2

  • INGREDIENTS AND APPEARANCE
    ABEJAS Y VIBORAS BRAND ROLL-ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-703-031 in 1 CARTON03/01/2021
    188 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2021
    Labeler - MENPER DISTRIBUTORS INC. (101947166)