Label: SCAR REDUCER INTENSIVE HERBAL AND NUTRIENT- allantoin cream

  • Category: HUMAN OTC DRUG LABEL

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 February 8, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Allantoin 1%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve chapped or cracked skin.

  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    If pregnant or nursing, ask a health professional before use.

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

  • Directions

    • apply as needed
  • Other information

    • store in a cool, dry place away from light
  • Inactive ingredients

    Olive oil, Beeswax, Water, Tocopheryl Acetate (Vitamin E), Calendula Officinalis Extract, Echinacea Purpurea Extract, Lysine, Sweet Almond Oil, Propolis Extract, Roman Chamomile Extract, Gum Benzoin, Tocopherol (Vitamin E), Goldenseal Extract, Aloe Barbadensis Leaf Juice, Tamanu Seed Oil, Cajeput Oil, Tea Tree Leaf Oil, Bisabolol, Onion Extract, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3)

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: QUANTUM HEALTH
    PO BOX 2791, EUGENE, OR 97402

  • PRINCIPAL DISPLAY PANEL - 21 g Tube Box

    Quantum®
    HEALTH

    Scar
    Reducer

    Intensive Herbal &
    Nutrient Cream
    Allantoin 1%

    WITH VITAMIN E,
    OLIVE OIL, LYSINE,
    ALOE, & MORE

    WORKS ON
    NEW & EXISTING SCARS
    NEWLY HEALED WOUNDS
    STRETCH MARKS

    HELPS SMOOTH AND REDUCE
    THE APPEARANCE OF SCARS

    Ointment

    D E R M A

    Net Wt 21g / .75 OZ

    Principal Display Panel - 21 g Tube Box
  • INGREDIENTS AND APPEARANCE
    SCAR REDUCER   INTENSIVE HERBAL AND NUTRIENT
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (allantoin - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)  
    Lysine (UNII: K3Z4F929H6)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CHAMAEMELUM NOBILE WHOLE (UNII: 7NF3GE7IWR)  
    BENZOIN RESIN (UNII: GK21SBA74R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ONION (UNII: 492225Q21H)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-710-011 in 1 BOX10/25/2021
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/25/2021
    Labeler - Quantum, Inc (044806305)
    Establishment
    NameAddressID/FEIBusiness Operations
    SunDeep Corp189788201MANUFACTURE(70084-710)