82904-301 I DEW CARE FIX MY ZIT ACNE GEL TREATMENT

I DEW CARE FIX MY ZIT ACNE GELTREATMENT by

Drug Labeling and Warnings

I DEW CARE FIX MY ZIT ACNE GELTREATMENT 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 FIX MY ZIT ACNE GELTREATMENT- salicylic acid gel 
Memebox Corporation

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82904-301 I DEW CARE FIX MY ZIT ACNE GEL TREATMENT

Active ingredients

Salicylic Acid 0.55%

Purposes

Acne Treatment

Uses

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.

Warnings

For external use only. Do not use for other than intended purpose.

Directions

■ Apply directly to acne breakouts one to three times daily after cleansing.

■ If bothersome dryness or peeling occurs,reduce application to once a day or every other day.

Inactive ingredients

Water, Dipropylene Glycol, Silica, Panthenol, 1,2-Hexanediol, Glycerin, Carbomer, Propanediol, Tromethamine, Polyacrylate-13, Methylpropanediol, Hydrogenated Polyisobutene, Butylene Glycol, Polyglyceryl-10 Laurate, Ethylhexyl Palmitate, Ethylhexylglycerin, Avena Sativa (Oat) Kernel Extract, Cynara Scolymus (Artichoke) Leaf Extract, Hydrogenated Lecithin, Polyquaternium-51, Camellia Sinensis Leaf Water, Citrus Unshiu Peel Extract, Beta- Glucan, Sorbitan Isostearate, Ficus Carica (Fig) Fruit Extract, Centella Asiatica Extract, Ceramide NP, Tocopherol

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I DEW CARE FIX MY ZIT ACNE GELTREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82904-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.55 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)
WATER (UNII: 059QF0KO0R)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
GLYCERIN (UNII: PDC6A3C0OX)
TROMETHAMINE (UNII: 023C2WHX2V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
TANGERINE PEEL (UNII: JU3D414057)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
OAT (UNII: Z6J799EAJK)
TEA LEAF OIL (UNII: VC855RRT77)
FIG (UNII: TGD87RII2U)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CERAMIDE NP (UNII: 4370DF050B)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82904-301-01	20 mL in 1 TUBE; Type 0: Not a Combination Product	08/08/2022	07/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/08/2022	07/25/2024

Labeler - Memebox Corporation (067317179)

Registrant - Memebox Corporation (067317179)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA CO., LTD.		689512611	manufacture(82904-301)

Revised: 7/2024

Document Id: 1c870f09-9a25-9a96-e063-6294a90a087b

34390-5

Set id: e5b49100-76fa-f187-e053-2a95a90a5c58

Version: 4

Effective Time: 20240705