Label: DERMACED MAXIMUM STRENGTH ANTI-FUNGAL- undecylenic acid liquid

  • 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 June 29, 2017

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

  • DRUG FACTS:

  • Active Ingredient:

    Undecylenic Acid 25%

    Purpose:

    Anti-fungal

  • Uses:

    For cure of most: • ringworm (tinea corporis) • athletes foot (tinea pedis). For the relief of: • itching • scaling • creaking • burning • redness • soreness • irritation and discomforts which may accompany these conditions.

  • Warnings:

    For external use only.

    Ask a doctor before use 

    • on children under two-years of age.

    DO NOT USE

    on diaper rash. When using this product avoid contact with eyes.

    Stop use and ask a doctor If

    • irritation occurs • there is no improvement within four weeks.

    Keep out of reach of children.

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

  • Directions:

    • Clean and dry affected area with soap and water and dry thoroughly. • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. • For athletes foot and ringworm. If condition persists for longer, consult a physician, • Intended for use by normally healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician. • This product is not meant to be applied directly to the scalp or nails.

  • Other Ingredients:

    Cymbopogon Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    DERMACED MAXIMUM STRENGTH ANTI-FUNGAL 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71515-832
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CLOVE OIL (UNII: 578389D6D0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71515-832-011 in 1 BOX06/29/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/29/2017
    Labeler - Dermaced, LLC (080703517)