Label: PROVAULT COOLING ROLL ON- menthol, camphor 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 October 19, 2022

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  • Active Ingredients

    Menthol USP 8%, Camphor USP 2%

  • Purpose

    Purpose
    External Analgesic

  • Keep out of reach of children

    Keep out of reach of children

  • Uses

    Temporary relief of monor aches and pains of muscles and joints associated with strains, bruises and sprains.

  • Warnings

    For external use only.

  • Directions

    Apply to affected area not more than 3 to 4 times daily. After each application, wash hands with soap and water (unless applying to hands). Children under the age of 18, consult a doctor before use.

  • Inactive Ingredients

    Aloe Baradensis (Aloe) Leaf Juice, Aqua/Purified Water, Arnica Montana (Arnica) Flower Extract, Cannabidiol (CBD), Chamomilla Recutita (Chamomile) Flower Extract, Gluconolactone, Glycerin (Kosher Vegetable), Hemp Seed Oil, Lonicera Japonica (Honeysuckle) Flower Extract, Mentha Arvensis (mint) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol (Natural Vitamin E), Xanthan Gum.

  • Questions or Comments

    Call 866 419 0043

  • PRINCIPAL DISPLAY PANEL

    Label

  • PRINCIPAL DISPLAY PANEL

    unit Carton

  • INGREDIENTS AND APPEARANCE
    PROVAULT COOLING ROLL ON 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-6100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.08 g  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL).02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    glycerin (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HEMP (UNII: TD1MUT01Q7)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-6100-188.7 g in 1 BOTTLE; Type 0: Not a Combination Product10/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/19/2022
    Labeler - Sombra Cosmetics Inc (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sombra Cosmetics097464309manufacture(61577-6100) , label(61577-6100)
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