Label: BERRI-FREEZ- menthol spray

  • 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 12, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient:    

    Menthol USP 10%

  • Purpose:

    Cooling Pain Reliever

  • Uses:

    Temporary relief of minor aches and pains related to:

    • Back, Shoulder, and Neck strains
    • Ankle, Knee, Hip and Elbow joint discomfort
    • Muscle sprains and strains
    • Arthritis
  • Warnings:

    For external use only. Keep out of reach of children.

  • WARNINGS

    Flammable: Keep away from excessive heat or open flame. If accidnetally ingested, get medical help or contact a Poison Control Center immediately.

    When using this Product:

    Avoid contact with the eyes or mucous membranes

    Do not apply to wounds or damaged skin

    Do not apply to irritated skin or if excessive irritation develops

    Do not bandage

    Wash hands after use with cool water

    Do not use with heating pad or device

  • STOP USE

    Stop Use and ask a Doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up or reoccur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:
    1-2 sprays on the affected areas as needed but not more than 4 times daily; massage not necessary.

  • Inactive Ingredients:

    Arnica Montana, Calendula, Chamomile, Echinacea, Ethanol, ILEX Paragurenis, Isopropyl Myristate, Juniper Berry, Water, White Tea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BERRI-FREEZ 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11.8 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WHITE TEA (UNII: O0M3396E09)  
    ALCOHOL (UNII: 3K9958V90M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-002-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-002)
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