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

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.

----------

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

IDC_Tea Tree-O StarterKit

I DEW CARE TEA TREE O STARTERKIT 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82904-304
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82904-304-011 in 1 KIT; Type 0: Not a Combination Product09/27/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 50 mL  in 100 
Part 21 BOTTLE 11 mL  in 100 
Part 31 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82904-303-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00609/27/2022
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82904-305-0111 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/27/2022
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) (MELALEUCA ALTERNIFOLIA LEAF - UNII:G43C57162K) MELALEUCA ALTERNIFOLIA LEAF0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82904-306-0124 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/27/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00609/27/2022
Labeler - Memebox Corporation (067317179)
Registrant - Memebox Corporation (067317179)
Establishment
NameAddressID/FEIBusiness Operations
KOLMAR KOREA CO., LTD.689512611manufacture(82904-304)

Revised: 6/2023
Document Id: fe38fb5e-e1f2-b20e-e053-6394a90a3241
Set id: e9b39692-4ae1-0b77-e053-2995a90aeebb
Version: 3
Effective Time: 20230616
 
Memebox Corporation