Label: ULTRA BLUE- 4% 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 April 19, 2019

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

View All Sections
  • Active ingredient section

    Menthol (4%)

  • Purpose

    Topical Analgesic

  • Uses:

    Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, strains, bruises.

  • Warnings

    For external use only.

  • Stop Use and Ask a Doctor If

    • Condition worsens

    • Symptoms last more than 7 days or clear up and occur again within a few days

    • A rash or irritation develops

  • Keep out of reach of children

    If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • When Using This Product

    • Do not apply to wounds or damaged skin

    • Do not bandage tightly

    • Do not use in or near the eyes; if product gets into eyes, rinse thoroughly with water

    • Do not use with electric heating pad

  • Directions

    • Adults and children 2 years and older, apply directly to affected area; not more than 3 or 4 times daily

    • Children under 2 years, ask a doctor

  • Inactive Ingredients:

    Purified Water, Propylene Glycol, Emu Oil, Methylsulfonylmethane (msm), Polyacrylamide (and) C13-14 Isoparaffin and Laureth-7, C12-15 Alkyl Benzoate, Dimethicone, Dioctyl Adipate (and) Octyl Stearate (and) Octyl Palmitate, White Willow Extract, Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben, Aloe Vera Gel, Panthenol, Ascorbic Acid, Capsicum Oleoresin, Cornflower Extract, Chamomile Extract, Feverfew Extract, Hypericum Extract, Calendula Extract, Linden Extract, Coriander Oil, Grape Seed Extract, Benzophenone-4, Polysorbate-20, Tetrasodium EDTA, Citric Acid, Fragrance, F D & C Blue #1 Lake

  • Ultra Blue tube front panel, back panel

    Ultra Blue Tube

  • INGREDIENTS AND APPEARANCE
    ULTRA BLUE 
    4% menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70632-825
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.56 g  in 114 g
    Inactive Ingredients
    Ingredient NameStrength
    EMU OIL (UNII: 344821WD61)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70632-825-045000 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2018
    Labeler - BNG Enterprises DBA Herbal Clean (781993902)
    Establishment
    NameAddressID/FEIBusiness Operations
    Personal Care Performance Group144297160manufacture(70632-825)
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!