82904-304 I DEW CARE TEA TREE-O STARTER KIT

I DEW CARE TEA TREE O STARTERKIT by

Drug Labeling and Warnings

I DEW CARE TEA TREE O STARTERKIT by is a Otc medication manufactured, distributed, or labeled by Memebox Corporation, KOLMAR KOREA CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

I DEW CARE TEA TREE O STARTERKIT- salicylic acid 
Memebox Corporation

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82904-304 I DEW CARE TEA TREE-O STARTER KIT

Active Ingredient

Salicylic Acid 1.5%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

Warnings

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Warnings

Stop use and ask a doctor if skin irritation occurs or gets worse.

Warnings

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

Directions

■ Pump 1~2 times and massage on wet face in circular motions. ■ Rinse thoroughly with clean water.
■ Use daily. AM & PM. ■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water, Dipropylene Glycol, Glycerin, Disodium Cocoamphodiacetate, Methylpropanediol, Lauryl Hydroxysultaine, Sodium Chloride, Sodium Cocoyl Alaninate, Coco-Betaine, Tromethamine, Acrylates Copolymer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Citric Acid, Hexylene Glycol, Laminaria Japonica Extract, Eclipta Prostrata Leaf Extract, 1,2-Hexanediol, Fructooligosaccharides, Butylene Glycol, Beta-Glucan, Hydrogenated Lecithin, Melaleuca Alternifolia (Tea Tree) Extract, Hydrolyzed Hyaluronic Acid, Propanediol, Citrus Unshiu Peel Extract

Label

I DEW CARE TEA TREE O STARTERKIT 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82904-304

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82904-304-01	1 in 1 KIT; Type 0: Not a Combination Product	09/27/2022	07/25/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	50 mL  in 100
Part 2	1 BOTTLE	11 mL  in 100
Part 3	1 POUCH	24 mL  in 100

Part 1 of 3

I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSER 
salicylic acid liquid

Product Information
Item Code (Source)	NDC: 82904-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAMINARIA JAPONICA (UNII: WE98HW412B)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
TROMETHAMINE (UNII: 023C2WHX2V)
ROSEMARY OIL (UNII: 8LGU7VM393)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COCO-BETAINE (UNII: 03DH2IZ3FY)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)
LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
TANGERINE PEEL (UNII: JU3D414057)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82904-303-02	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/27/2022	07/25/2024

Part 2 of 3

I DEW CARE ROLL WITH TEA TREE ROLL ON FACEOIL 
tea tree oil oil

Product Information
Item Code (Source)	NDC: 82904-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
APPLE SEED OIL (UNII: 9ACA4K9013)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82904-305-01	11 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/27/2022	07/25/2024

Part 3 of 3

I DEW CARE HERES THE TEA TREE 
tee tree oil patch

Product Information
Item Code (Source)	NDC: 82904-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) (MELALEUCA ALTERNIFOLIA LEAF - UNII:G43C57162K)	MELALEUCA ALTERNIFOLIA LEAF	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCOA (UNII: D9108TZ9KG)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
MONARDA DIDYMA LEAF (UNII: JY15982UBB)
APPLE (UNII: B423VGH5S9)
WINE GRAPE (UNII: 3GOV20705G)
PAPAYA (UNII: KU94FIY6JB)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
TEA TREE OIL (UNII: VIF565UC2G)
4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
FRAGRANCE 13576 (UNII: 5EM498GW35)
ICODEXTRIN (UNII: 2NX48Z0A9G)
MENTHA SUAVEOLENS LEAF (UNII: 1341ZC68MK)
MATRICARIA RECUTITA LEAF (UNII: 6I9LN466F0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
BETAINE (UNII: 3SCV180C9W)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TREHALOSE (UNII: B8WCK70T7I)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ARGININE (UNII: 94ZLA3W45F)
GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER (300000 CP AT 2%) (UNII: MEA9KH24QG)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHAMOMILE (UNII: FGL3685T2X)
COPOVIDONE K25-31 (UNII: D9C330MD8B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82904-306-01	24 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/27/2022	07/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/27/2022	07/25/2024

Labeler - Memebox Corporation (067317179)

Registrant - Memebox Corporation (067317179)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA CO., LTD.		689512611	manufacture(82904-304)

Revised: 7/2024

Document Id: 1c872870-586b-0bf8-e063-6394a90a7c44

34390-5

Set id: e9b39692-4ae1-0b77-e053-2995a90aeebb

Version: 4

Effective Time: 20240705