Label: AL0040600 ALBA COOLING ALOE BURN RELIEF- menthol, allantoin spray

  • NDC Code(s): 61995-2406-6
  • Packager: The Hain Celestial Group, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 10, 2019

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

  • ACTIVE INGREDIENT

    Allantoin 0.5%

    Menthol 0.5%

  • PURPOSE

    Mentol - Topical Analgetic

    Allantoin - Skin Protectant

  • INDICATIONS & USAGE

    • Provides cooling pain relieve
    • Skin protection and first aid for the temporary relief of pain and itching associated with sunburn, minor burns, minor skin irritations, insect bites, minor cuts and scrapes

  • WARNINGS

    For external use only. Avoid contact with eyes, mouth and mucous membranes. Do not use on deep puncture wounds, animal bites or serious burns. Do not puncture or incinerate. Contents under preassure .Do not store at temperature above 120°. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if condition worsens, lasts more than 7days or clears up and occurs again in within a few days or if skin rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years old and older: apply to affected area up to 4 times daily or as directed by doctor. Hold 4-6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Sprayon hand and apply to face.Use in well-ventiled area. Children under 2 years of age : ask a doctor.

  • INACTIVE INGREDIENT

    Aquq (Water),Glycerin, Caprylyl/Capric Glucoside, Aloe Barbadensis Leaf Juice, Cananga Odarata Flower Oil, Mentha Piperita (Peppermint) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric Trigluceride, Citric Acid, Terpineol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Hexyl Cinnamal, Hydroxycitronellol, Limonene, Linalool.

  • QUESTIONS

    Questions?Visit www.albabotanica.com or call 888-659-7730

  • PRINCIPAL DISPLAY PANEL

    cane label

  • INGREDIENTS AND APPEARANCE
    AL0040600 ALBA COOLING ALOE BURN RELIEF 
    menthol, allantoin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2406
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    APPLE (UNII: B423VGH5S9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CUCUMBER (UNII: YY7C30VXJT)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDROXYCITRONELLOL (UNII: R0B4U2I48W)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2406-6177 g in 1 CAN; Type 0: Not a Combination Product01/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/13/2016
    Labeler - The Hain Celestial Group, Inc (117115556)
    Registrant - The Hain Celestial Group, Inc. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc117115556manufacture(61995-2406)