Label: ARC SKIN PROTECTANT- allantoin ointment

  • NDC Code(s): 69148-001-00, 69148-001-01, 69148-001-02
  • Packager: Anjon Biologics, Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 18, 2024

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  • PURPOSE

    Protection Against Radiation Dermatitis

  • Indication for use •

    ARC® is a pre-radiation topical cream treatment for the protection against and management of Radiation Dermatitis.

  • Directions •

    For topical use only. Apply ARC® twice daily to all skin areas that will be exposed to radiation, or as directed by a health care professional. Can be applied 1-2 hours prior to treatment. Massage gently into the skin until absorbed. Continue use until treatment cycle is complete. Washing of the treated area will not reduce skin protection. ARC® does not interfere with the effectiveness of radiation treatment.

  • Ingredients •

    Each gram contains 5 mg (0.5%) Allantoin in a cream base of

  • INACTIVE INGREDIENT

    Aloe Vera Leaf Gel, Bees Wax White, BHT, Cetyl Alcohol, DMDM H, Glycerin, Glyceryl Stearate SE, Isopropyl Myristate, Mineral Oil, Nipagin, Nipasol, Polydimethylsiloxane (PDMS), Polysorbate 60, Polysorbate 20, Sesame Oil, Shea Butter, Sorbitan Tristearate, Water

  • OTHER SAFETY INFORMATION

    Store at room temperature. Avoid excessive heat. Do not freeze.

  • Warnings

    For external use only. Should you have an adverse reaction, consult your physician.

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    NATURAL CREAM

    THERGY

    Cancer Care Solutions

    Las Vegas, NV 89117
    thergy.com

    Made in USA

  • Packaging

    ARC-001

  • 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)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69148-001-00118.6 g in 1 TUBE; Type 0: Not a Combination Product08/06/201404/22/2024
    2NDC:69148-001-0160 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    3NDC:69148-001-02100 g in 1 TUBE; Type 0: Not a Combination Product04/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/06/2014
    Labeler - Anjon Biologics, Inc (054126951)
    Registrant - Anjon Biologics, Inc (054126951)
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