Label: SCAR CREAM- allantoin cream cream

  • 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 July 12, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients

    Allantoin 1% Skin Protectant

  • PURPOSE

    Skin protectant

  • INDICATIONS & USAGE

    temporarily protects and helps relieve chapped or cracked skin

  • WARNINGS

    Warnings

    For external use only

    Do not get into 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

    Do not use on deep or punctured wounds, animal bites, serious burns

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Apply as needed

  • INACTIVE INGREDIENT

    CENTELLA ASIATICA

    CYCLOMETHICONE 5
    PHENYL TRIMETHICONE
    ALKYL (C12-15) BENZOATE
    CARBOMER INTERPOLYMER TYPE A (55000 CPS)
    WATER
    CLOVE OIL
    ALOE VERA LEAF
    CETYL ALCOHOL
    ONION
    GLYCERIN
    STEARIC ACID
    EDETIC ACID
    GLYCERYL STEARATE/PEG-100 STEARATE
    MELALEUCA ALTERNIFOLIA LEAF
    BUTYLATED HYDROXYTOLUENE
    SODIUM HYDROXIDE
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
    PHYLLANTHUS EMBLICA WHOLE
    TAMARIND
    CETOSTEARYL ALCOHOL

    CETEARYL GLUCOSIDE​

  • PRINCIPAL DISPLAY PANEL

    Scar Cream

  • INGREDIENTS AND APPEARANCE
    SCAR CREAM 
    allantoin cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72982-1905
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    CLOVE OIL (UNII: 578389D6D0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ONION (UNII: 492225Q21H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    PHYLLANTHUS EMBLICA WHOLE (UNII: 9B45E1E94Z)  
    TAMARIND (UNII: 2U9H66X7VX)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72982-1905-1120 g in 1 CONTAINER; Type 0: Not a Combination Product07/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/08/2019
    Labeler - Everyday Medical LLC (117001767)
    Registrant - Everyday Medical LLC (117001767)
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