Label: HONGOSAN DSP- tolnaftate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 70826-576-07, 70826-577-02 - Packager: Dsp Skin Care Products
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients:
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- WARNINGS
- Directions
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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
- Packaging
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INGREDIENTS AND APPEARANCE
HONGOSAN DSP
tolnaftate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70826-576 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70826-576-07 1 in 1 KIT; Type 0: Not a Combination Product 07/09/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 JAR 56.7 g Part 2 1 BOTTLE, DROPPER 14.8 mL Part 3 1 BOX 1 Part 1 of 3 HONGOSAN DSP CREAM
tolnaftate creamProduct Information Item Code (Source) NDC:70826-577 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70826-577-02 56.7 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/09/2016 Part 2 of 3 HONGOSAN DSP DROPS
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR IODINE (UNII: 9679TC07X4) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14.8 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 3 of 3 HONGOSAN DSP SOAP
bath soaps and detergentsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GLYCERIN (UNII: PDC6A3C0OX) INGR WATER (UNII: 059QF0KO0R) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 BOX; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/09/2016 Labeler - Dsp Skin Care Products (070967913) Establishment Name Address ID/FEI Business Operations Dsp Skin Care Products 070967913 manufacture(70826-576, 70826-577)