Label: ARC SKIN PROTECTANT- allantoin ointment

  • NDC Code(s): 69148-001-00, 69148-001-01
  • Packager: Anjon Biologics, 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 January 1, 2019

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  • ARC Skin Protectant Ointment


  • Active Ingredient / Purpose


    Allantoin 0.5% .............................. Skin Protectant

  • Use

    • temporarily protects minor burns
  • Warnings

    For external use only


    Do not use on
    • deep or puncture wounds
    • animal bites
    • serious burns
    When using this product
    • 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
    • your skin shows significant sign of irritation or discomfort

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

  • Directions

    Apply as needed

  • Other information

    • Keep in a cool place or out of direct sunlight
  • Inactive Ingredients

    aloe vera leaf gel, benzoic acid, benzyl alcohol, cetyl alcohol, citric acid, coconut oil, glycenn, imidazolidinyl urea, isopropyl mylistate, jojoba seed oil, methylisothiazolinone, mineral water, shea butter, sorbitan histearate, vitamin A, vitamin E acetate

  • Questions or comments?

    USA 1-855-434-0300

  • ARC Skin Protectant Ointment 4oz/118.6g (69148-001-00)

    ALL NATURAL CREAM

    ARC

    Protection for Radiation Dermatitis

    ARCLabel
  • INGREDIENTS AND APPEARANCE
    ARC SKIN PROTECTANT 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69148-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IMIDUREA (UNII: M629807ATL)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JOJOBA OIL (UNII: 724GKU717M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    VITAMIN A (UNII: 81G40H8B0T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69148-001-00118.6 g in 1 TUBE; Type 0: Not a Combination Product08/06/2014
    2NDC:69148-001-0160 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/06/2014
    Labeler - Anjon Biologics, Inc (054126951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anjon Biologics, Inc054126951manufacture(69148-001)