Label: HONGOSAN DSP- tolnaftate kit

  • 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 July 9, 2016

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  • Drug Facts

  • Active ingredients:

    Tolnaftate 1%

  • Purpose

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center

  • Uses

    - Relieves most external fungal infections.

    - Relieves most ringworm infections.

    - Relieves most dermic infections.

    - Relieves itching, burning, cracking, irritation and scaling.

  • WARNINGS

    Warning- The safety of this product has not been determined. For external use only. Do not use in or near the mouth or eyes. In case of exposure, rinse thoroughly with water.

  • Directions

    Wash the affected area with Hongosan Soap. Dry, and then use the Hongosan Liquid Drops, Wait 5 min., then apply the Hongosan Cream.

  • Inactive ingredients:

    Water, Glycerin, Tea tree oil, Stearic acid, Isopropyl Palmitate, Glycol Stearate, PEG-100 Stearate, Mineral oil, Dimethicone, Petrolatum, Glyceryl Stearate, Phenoxyethanol, Cetyl alcohol, Methylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Stearamide AMP, Cedrol and Hydroxyethyl Urea.

  • SPL UNCLASSIFIED SECTION

    With Tea Tree Oil

    ONLY ONE ANTI-BACTERIAL ACTION

    PREMIUM PLUS

    ANTI-FUNGAL ANTI-INFECTIOUS - PROTECTOR

    3-Piece Set
    (Cream, Anti-septic Liquid and Soap)

    Manufactured by:
    DSP Skin Care Products
    Los Angeles, CA 90057
    1-844-389-2366

  • Packaging

    Hongset

  • INGREDIENTS AND APPEARANCE
    HONGOSAN DSP 
    tolnaftate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70826-576
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70826-576-071 in 1 KIT; Type 0: Not a Combination Product07/09/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 JAR 56.7 g
    Part 21 BOTTLE, DROPPER 14.8 mL
    Part 31 BOX 1 
    Part 1 of 3
    HONGOSAN DSP CREAM 
    tolnaftate cream
    Product Information
    Item Code (Source)NDC:70826-577
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARAMIDE AMP (UNII: U3K8640346)  
    CEDROL (UNII: 63ZM9703BO)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70826-577-0256.7 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/09/2016
    Part 2 of 3
    HONGOSAN DSP DROPS 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRIODINE (UNII: 9679TC07X4)  
    INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114.8 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 3
    HONGOSAN DSP SOAP 
    bath soaps and detergents
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/09/2016
    Labeler - Dsp Skin Care Products (070967913)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dsp Skin Care Products070967913manufacture(70826-576, 70826-577)
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