HONGOSAN DSP- tolnaftate 
Dsp Skin Care Products

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.

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HONGOSAN DSP KIT

Drug Facts

Active ingredients:

Tolnaftate 1%

Purpose

Antifungal

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.

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.

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

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)

Revised: 7/2016
Document Id: ce767775-e3b9-46bd-b7ee-390cbfc7ce50
Set id: 901833f1-62eb-4273-93a4-ce20d006ffe8
Version: 1
Effective Time: 20160709
 
Dsp Skin Care Products