Label: ALLANTOIN- advanced derma spray aerosol, spray

  • NDC Code(s): 56104-034-85
  • Packager: Premier Brands of America 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 March 27, 2018

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

  • Active ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve chapped or cracked skin

  • Warnings

    For external use only.

    Contents under pressure. Do not puncture or incinerate. Do not store above 120 °F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns

    When using this product

    • avoid spraying in eyes

    Stop use and ask a doctor if

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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well before using
    • apply as needed
    • spray product onto affected area(s) and massage into skin in a circular motion
    • for scars on face or near eyes spray product into palm of hand and apply with fingertips
  • Other information

    store at room temperature

  • Inactive ingredients

    Water, Dimethyl Ether, Isostearyl Isostearate, Isopropyl Isostearate, PPG-3 Benzyl Ether Myristate, Pentaerythrityl Tetracaprylate/Caprate, Methylsilanol Hydroxyproline Aspartate, Glycerin, Butylene Glycol, Allium Cepa (Onion) Bulb Extract, Sucrose Palmitate, Glyceryl Stearate, Glyceryl Stearate Citrate, Sucrose, Mannan, Xanthan Gum, Cetyl Hydroxyethylcellulose, Rutin, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phaseolus Lunatus (Green Bean) SEed Extract, Phenoxyethanol, Fragrance, Potassium Sorbate, Salicylic Acid

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Premier

    Advanced Derma Spray

    Allantoin 0.5% - Skin Protectant

    Improves overall appearance of SCARS*
    Improves the appearance of texture & smoothness on STRETCH MARKS*
    Dermatologist tested
    Paraben Free

    Shake well before use.

    Net WT 3 OZ (85 g)

    Generic_Advanced Derma Spray_50-126XX-01.jpg

    Generic_Advanced Derma Spray_50-126XX-01.jpg

  • INGREDIENTS AND APPEARANCE
    ALLANTOIN 
    advanced derma spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.425 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL ETHER (UNII: AM13FS69BX)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ONION (UNII: 492225Q21H)  
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SUCROSE (UNII: C151H8M554)  
    YEAST MANNAN (UNII: 91R887N59P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    RUTIN (UNII: 5G06TVY3R7)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    LIMA BEAN (UNII: 112YH1ZMX2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-034-8585 g in 1 CAN; Type 0: Not a Combination Product03/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/27/2018
    Labeler - Premier Brands of America Inc. (080051232)