2023-10-09 De-listing 74472-007_SOME BY MI CHARCOAL BHA PORE CLAY BUBBLE MASK

SOME BY MI CHARCOAL BHA PORE CLAY BUBBLE MASK by

Drug Labeling and Warnings

SOME BY MI CHARCOAL BHA PORE CLAY BUBBLE MASK by is a Otc medication manufactured, distributed, or labeled by PERENNEBELL Co., Ltd., reBom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOME BY MI CHARCOAL BHA PORE CLAY BUBBLE MASK- salicylic acid cream 
PERENNEBELL Co., Ltd.

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2023-10-09 De-listing 74472-007_SOME BY MI CHARCOAL BHA PORE CLAY BUBBLE MASK

Salicylic Acid 0.5%

Acne Treatment

For the treatment of Acne

Apply an appropriate amount onto the dry skin. When the bubble foam up, enjoy the bubble pack for 3-5 minutes, and gently massage with small amount of water. Wash off with lukewarm water.

For external use only
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. avoid contact with eyes. If contact occurs, flush thoroughly with water.
People with allergy to aspirin will react poorly to the Salicylic Acid.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Butylene Glycol, Sodium Cocoyl Isethionate, Glycerin, Kaolin, Charcoal Powder, Disodium Laureth Sulfosuccinate, Methyl Perfluoroisobutyl Ether, Sodium Methyl Cocoyl Taurate, Lauric Acid, Potassium Cocoyl Glycinate, Coco-Betaine, Methyl Perfluorobutyl Ether, Acrylates Copolymer, Manicouagan Clay, Melaleuca Alternifolia (Tea Tree) Leaf Water, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Artemisia Princeps Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Madecassic Acid, Madecassoside, Asiaticoside, Asiatic Acid, Ascorbyl Glucoside, Glutathione, Caprylyl Glycol, Citric Acid, Water(Carbonated Water), Benzyl Glycol, Ethylhexylglycerin, Raspberry Ketone, Disodium EDTA, Fragrance

SOME BY MI CHARCOAL BHA PORE CLAY BUBBLE MASK 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74472-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
METHYL PERFLUOROISOBUTYL ETHER (UNII: HI89P35AAX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
LAURIC ACID (UNII: 1160N9NU9U)
POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)
COCO-BETAINE (UNII: 03DH2IZ3FY)
METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U)
TEA TREE OIL (UNII: VIF565UC2G)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
APPLE (UNII: B423VGH5S9)
MADECASSIC ACID (UNII: M7O1N24J82)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
ASIATICOSIDE (UNII: PKO39VY215)
ASIATIC ACID (UNII: 9PA5A687X5)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
GLUTATHIONE (UNII: GAN16C9B8O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74472-007-02	1 in 1 CARTON	04/27/2022
1	NDC: 74472-007-01	120 g 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	04/27/2022	10/09/2023

Labeler - PERENNEBELL Co., Ltd. (694788814)

Registrant - PERENNEBELL Co., Ltd. (694788814)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd.		688733595	manufacture(74472-007)

Revised: 10/2023

Document Id: 0736e133-3401-7d24-e063-6294a90a4e79

34390-5

Set id: 07b68784-6e3f-46c5-804a-44de54388c6b

Version: 2

Effective Time: 20231008