Label: KURIBL ACTIVE COOLING ROLL-ON- camphor, menthol liquid

  • NDC Code(s): 83111-001-01
  • Packager: Radiance Beauty & Wellness Inc. dba Saavy Naturals
  • 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 January 10, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Camphor 2% External Analgesic

    Menthol 8% External Analgesic

  • PURPOSE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if

    • condition worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation develops

  • WARNINGS

    WarningsFor external use only

    Do not use on wounds or damaged skin

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly or use with a heating pad

    If pregnant or breast feeding ask a health professional before use

  • DOSAGE & ADMINISTRATION

    Directions

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

    Inactive Ingredients Aloe barbadensis (Aloe) Leaf Juice, Arnica montana (Arnica) Flower Extract, Aqua/ Purified Water, Capsicum frutescens (Chili Pepper) Fruit Extract, Gluconolactone, Glycerin (Kosher Vegetable), Lonicera caprifolium (Honeysuckle) Flower Extract, Lonicera japonica (Honeysuckle) Flower Extract, Tocopherol (Natural Vitamin E), Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Kuribl Active

    Cooling Roll-on

    All Natural Pain Relief

    with Camphor & Menthol

    3 FL OZ (88.7 mL)

    Kuribl roll on

  • INGREDIENTS AND APPEARANCE
    KURIBL ACTIVE COOLING ROLL-ON 
    camphor, menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83111-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    WATER (UNII: 059QF0KO0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83111-001-0188.7 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2023
    Labeler - Radiance Beauty & Wellness Inc. dba Saavy Naturals (047080443)
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