HONGOSAN DSP- tolnaftate kit

HONGOSAN DSP by

Drug Labeling and Warnings

HONGOSAN DSP by is a Otc medication manufactured, distributed, or labeled by Dsp Skin Care Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HONGOSAN DSP 
tolnaftate kit

Product 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 cream

Product 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 detergents

Product 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)