Label: TOBCHARM- 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 September 6, 2023

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  • Active ingredients

    Undecylenic Acid 10%

  • Purpose

    Anti-Fungal

  • Uses

    Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.

  • Warnings

    For external use only

    Do not use

    • on irritated skin and any area that is infected or reddened 
    • if pregnant or if there is any allergic reaction to this product.

    When using this product

    • avoid contact with eyes.

    Stop use and ask a doctor if

    • if discomfort persists

    Keep out of reach of children.

    • if product get into eyes, flush with water for 15 minutes 
    • if swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Wash feet thoroughly with warm water, and gently file thickened part of the fungal nail with a nail file until its flat
    • apply layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail. 
    • after the liquid has been absorbed, apply a layer of the cream to the infected parts of the nail 
    • repeat the process if necessary once a day  
  • Other information

    Store at room temperature and our of direact sunlight. Skin discoloration may occur during or after use.

  • Inactive ingredients

    mineral oil, apricot kernel oil, tea tree oil, tocopherol, peppermint oil, camphor oil, jojoba oil, bergamot oil, lavender oil

  • SPL UNCLASSIFIED SECTION

    Questions ? Email at

    service@Tobcharm.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TOBCHARM 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83462-002-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/05/2023
    Labeler - EUbizrival LLC (036572203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Pallas Cosmetics Co.,Ltd.419564106manufacture(83462-002)
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