Label: REMEDY NAILS- undecylenic acid lotion

  • 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 May 22, 2023

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  • ACTIVE INGREDIENT:

    Undecylenic Acid USP 10%

  • PURPOSE:

    Anti-Fungal

  • USES:

    Treats cuticle and skin fungal infections.

    • Heals and moisturizes cuticles and skin.
    • Athlete's foot treatment.
    • Relieves itching, burning and cracking.
  • WARNINGS: FOR EXTERNAL USE ONLY.

    Keep out of reach of children.

    • Consult your doctor if you are pregnant before using this product.
    • It is not known whether this drug passes into breast milk.
    • Consult your doctor before breast feeding.
    • If swallowed, call Poison Control Center immediately.
  • STOP USE AND ASK A DOCTOR IF:

    Irritation occurs.

    • No improvement within 2 weeks.
  • DIRECTIONS:

    Wash and dry affected area.

    • Apply a thin layer over affected area twice daily or as directed by a doctor.
    • Apply enough medication to cover the affected area and surrounding skin.
    • Wash hands after use.
    • For maximum results, use twice daily or as instructed.
    • Discontinuing use of this medication may allow recurrence of infection.
    • If condition persists, consult your doctor.
  • CAUTION:

    Do not accept if safety seal is broken or missing.

    • Store at room temperature 60-85F.
    • Keep in tight, light resistant container.
  • ALLERGIC REACTIONS:

    Contact doctor if unusual reactions to this medicine occur.

    • This product does not contain FD&C Yellow #5 or FD&C Yellow #6.
  • INACTIVE INGREDIENTS:

    Mineral Oil, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Linalool, Carthamus Tinctorius (Safflower) Seed Oil, Limonene, Aleurites Moluccana (Kukui) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Algae Extract.

  • Principal Display Panel - 15 mL Bottle Label

    Dr.'s REMEDY®
    Therapeutic Cuticle Oil

    Lavender
    Safflower
    Tea Tree Oil
    Algae Extract

    Nourishing
    Anti-Fungal
    Treatment

    15mL

    Principal Display Panel - 15 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    REMEDY NAILS 
    undecylenic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72222-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID85 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72222-224-101 in 1 CARTON06/01/2018
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2018
    Labeler - Adwill Labs Inc (081136982)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc.624386772manufacture(72222-224)
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