Label: CVS PHARMACY MAXIMUM STRENGTH ANTIFUNGAL LIQUID WITH ALOE AND VITAMIN E- 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 January 11, 2017

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  • Drug Facts

    Active Ingredient

    Undecylenic acid 25% w/v

    Purpose

    Antifungal

  • Uses

    For the cure of:

    • ringworm (tinea corporis)
    • athlete's foot (tinea pedis)

    For the relief of:

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
  • Warnings

    For external use only

    Flammable:Keep away from fire or flame.

    Do not use on children under 2 years of age unless directed by a doctor.

    If pregnant or breastfeeding ask a health professional before use.

    When using this product

    avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs.
    • there is no improvement within 4 weeks.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Read all warnings and directions.
    • Use only as directed.
    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of product over the affected area twice daily (morning and night) or as directed by a doctor.
    • Supervise children in the use of this product.
    • For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • For athlete's foot and ringworm, use daily for 4 weeks.  If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Other information

    • Store at 20 o-25 oC (68 o-77 oF)
    • Keep container tightly closed when not in use.
  • Inactive ingredients

    Aloe barbadensis leaf juice, Fragrance, Hypromellose, Isopropyl alcohol, Tocopheryl acetate (Vitamin E), Water

  • PRINCIPAL DISPLAY PANEL

    Label and carton

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  MAXIMUM STRENGTH ANTIFUNGAL LIQUID WITH ALOE AND VITAMIN E
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-718
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.25 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-718-211 in 1 CARTON05/01/2010
    10.04 L in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/01/2010
    Labeler - CVS Pharmacy (062312574)
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