2023-10-09 De-listing 74472-006_SOME BY MI AHA-BHA-PHA REAL CICA 92% COOL CALMING SOOTHING GEL

SOME BY MI AHA BHA PHA REAL CICA 92% COOL CALMING SOOTHING gel by

Drug Labeling and Warnings

SOME BY MI AHA BHA PHA REAL CICA 92% COOL CALMING SOOTHING gel 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 AHA BHA PHA REAL CICA 92% COOL CALMING SOOTHING GEL- salicylic acid gel 
PERENNEBELL Co., Ltd.

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2023-10-09 De-listing 74472-006_SOME BY MI AHA-BHA-PHA REAL CICA 92% COOL CALMING SOOTHING GEL

Salicylic Acid 0.001%

Acne Treatment

For the treatment of Acne

After lightly shaking the product, apply it following the skin texture using fingertip. After applying the product, cover your face with hand for better absorption.

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.

Centella Asiatica Extract, Water, Niacinamide, Dipropylene Glycol, Hydroxyethyl Urea, Melaleuca Alternifolia (Tea Tree) Leaf Water, Artemisia Princeps Leaf Extract, Centella Asiatica Leaf Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Eclipta Prostrata Extract, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Helianthus Annuus (Sunflower) Seed Oil, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Madecassic Acid, Asiaticoside, Asiatic Acid, Madecassoside, Allantoin, Arginine, Adenosine, Lactobionic Acid, Citric Acid, C12-13 Pareth-9, Carbomer, 1,2-Hexanediol, Benzyl Glycol, Ethylhexylglycerin, Raspberry Ketone, Rosmarinus Officinalis (Rosemary) Leaf Oil

SOME BY MI AHA BHA PHA REAL CICA 92% COOL CALMING SOOTHING GEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74472-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.001 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
TEA TREE OIL (UNII: VIF565UC2G)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
HOLY BASIL LEAF (UNII: SCJ765569P)
CORALLINA OFFICINALIS (UNII: 4004498D06)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
MADECASSIC ACID (UNII: M7O1N24J82)
ASIATICOSIDE (UNII: PKO39VY215)
ASIATIC ACID (UNII: 9PA5A687X5)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
ADENOSINE (UNII: K72T3FS567)
LACTOBIONIC ACID (UNII: 65R938S4DV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
C12-13 PARETH-9 (UNII: 9BXD858P37)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
ROSEMARY OIL (UNII: 8LGU7VM393)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74472-006-02	1 in 1 CARTON	03/17/2021
1	NDC: 74472-006-01	300 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	03/17/2021	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(74472-006)

Revised: 10/2023

Document Id: 0736e51c-f2aa-e88e-e063-6394a90ac657

34390-5

Set id: 40c6878c-e118-4b32-a1d2-41d2f93cc501

Version: 3

Effective Time: 20231008