Label: OHEAL RINGWORM CREAM- ringworm cream cream

  • NDC Code(s): 83176-009-01
  • Packager: Dr.luke Healthcare LLC
  • 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 31, 2023

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Treat Skin Infections

  • Use

    Ringworm related such as tinea corporis, kerion, skin irritation, fungal infection, itching & inflammation, tinea capitis

  • Warnings

    For external use only
    Do not use on children under 2 years of age unless directed by a doctor
    When using this product avoid contact with eyes

  • Do not use

  • Do not use

    On broken skin
    On eyes area
    With any other drug

  • Stop Use

    lf you are allergic to this product.lf symptoms persist for over 7 days or worsen, consult your physician.lf you are pregnant or breast-feedingYou become pregnant or are planning to become pregnant while using this product

  • Keep Oot Of Reach Of Children

    Store this product in a suitable place.

  • Directions

    1.Wash the affected area and dry thoroughly
    2.Apply a thin layer over the affected area twice daily(morning and night), or as directed by a doctor.

  • Inactive ingredients

    Water, Herba Violae, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Oleth-10 Phosphate, Triethanolamine, Polysorbate 20, Acrylates Copolymer, Cnidium Monniericuss, CortexDictamnil, Glycerin, Propylene Glycol, Uva Ursi (Bearberry) Extract, Beta-Glucan, Propolis Extract, Aloe Barbadensis Juice, Vitamin E, Camphor, Menthol, Tea Tree Oil, Lavender Oil, Jasmine Oil, Clove Flower Oil, Theobroma Cacao Cocoa Seed Butter, Rose Hip Flower Oil, Cetyl Hydroxyethylcellulose, Phenoxyethanol,Ethylhexylglycerin，Mint

  • Questions

    www.ohealpro.com

    Info@ohealpro.com

  • PRINCIPAL DISPLAY PANEL

    001

  • INGREDIENTS AND APPEARANCE
    OHEAL RINGWORM CREAM 
    ringworm cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)  
    WATER (UNII: 059QF0KO0R)  
    OLETH-10 PHOSPHATE (UNII: Q95361F4VS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MINT (UNII: FV98Z8GITP)  
    VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54)  
    CNIDIUM MONNIERI FRUIT OIL (UNII: JK0MS9P8YL)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CLOVE OIL (UNII: 578389D6D0)  
    MENTHOL (UNII: L7T10EIP3A)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83176-009-0156 g in 1 BOTTLE; Type 0: Not a Combination Product05/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00505/31/2023
    Labeler - Dr.luke Healthcare LLC (118868014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.luke Healthcare LLC118868014label(83176-009) , manufacture(83176-009)
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