Label: CBD GLOBAL FREEZE- methyl salicylate, menthol, camphor 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 September 28, 2022

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  • Active Incredients

    Methyl Salicylate 30%

    Menthol 10%

    Camphor Oil 4%

  • Purpose

    Topical analgesi

  • Uses

    temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

  • Warnings

    for external use only

  • WHEN USING

    When using this prodcut• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin •do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develeps

  • KEEP OUT OF REACH OF CHILDREN

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

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions:

    Adults and children over 2 years:• apply generously to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily

    Children 2 years or younger: ask a doctor

  • Inactive ingredients

    Industrial Hemp CBD(200mg), CBG(10mg), CBN(10mg), Isopropyl Alcohol

  • Package Label

    Muscle Freeze Spray

  • INGREDIENTS AND APPEARANCE
    CBD GLOBAL FREEZE 
    methyl salicylate, menthol, camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-954
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CANNABINOL (UNII: 7UYP6MC9GH)  
    CANNABIGEROL (UNII: J1K406072N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-954-0225 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/28/2022
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-954) , pack(58133-954) , label(58133-954)
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