Label: ARUMACIL PROTECTANT COLD SORE- dimethicone, petrolatum ointment

  • 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 8, 2021

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  • Drug Facts

  • Active ingredients 

    Dimethicone 1.1%

    Petrolatum 92.8%

    Purpose

    Skin Protectant

  • Use

    • relieves dryness and softens cold sores and fever blisters
  • Warnings

    For external use only

    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

    Do not use on

    • deep or puncture wounds 
    • animal bites
    • serious burns

    Keep out of reach of children.

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

  • Directions

    • apply as needed
  • Inactive ingredients

    Arum Palaestinum, Beta-Sitosterol, Peganum Harmala, Turmeric, Vanillin, Vitamin C

  • Package Labeling:

    Outer LabelInner Label

  • INGREDIENTS AND APPEARANCE
    ARUMACIL PROTECTANT COLD SORE 
    dimethicone, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72933-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE11 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM928 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARUM PALAESTINUM WHOLE (UNII: 4E96UIB20M)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    TURMERIC (UNII: 856YO1Z64F)  
    VANILLIN (UNII: CHI530446X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72933-006-011 in 1 BLISTER PACK12/30/2020
    17.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/30/2020
    Labeler - Hyatt Life Sciences, Inc. (117495900)
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