81230-001_Inward Agas ACue Cleansing Foam

Inward Agas ACue Cleansing Foam by

Drug Labeling and Warnings

Inward Agas ACue Cleansing Foam by is a Otc medication manufactured, distributed, or labeled by INWARD. Co.,Ltd., Woosin Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INWARD AGAS ACUE CLEANSING FOAM- salicylic acid gel 
INWARD. Co.,Ltd.

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.

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81230-001_Inward Agas ACue Cleansing Foam

Salicylic Acid 0.5%

Acne Treatment

For the treatment of Acne

Take a penny-sized amount of the product in your palm and lather with water. Massage gently and thoroughly over the face, and rinse 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.

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

Water, Sodium C14-16 Olefin Sulfonate, Cocamide Methyl MEA, Glycerin, Decyl Glucoside, Disodium Cocoamphodiacetate, Sodium Methyl Cocoyl Taurate, Coco-Betaine, Butylene Glycol, Sodium Chloride, Propanediol, Citrus Aurantium Dulcis (Orange) Peel Oil, Agastache Rugosa Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Tetradecene, Hexadecene, Sodium Sulfate, Hexylene Glycol, Hydroxyacetophenone, Pentylene Glycol, Caprylyl Glycol, Citric Acid, Polyquaternium-10, Lactic Acid, Disodium EDTA, Morus Nigra Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Olea Europaea (Olive) Leaf Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Prunus Domestica Fruit Extract, Althaea Rosea Flower Extract, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens Flower Oil, Centella Asiatica Extract, Lavandula Angustifolia (Lavender) Oil, Copaifera Officinalis (Balsam Copaiba) Resin

INWARD AGAS ACUE CLEANSING FOAM 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81230-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCO-BETAINE (UNII: 03DH2IZ3FY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPANEDIOL (UNII: 5965N8W85T)
ORANGE OIL (UNII: AKN3KSD11B)
BERGAMOT OIL (UNII: 39W1PKE3JI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
1-TETRADECENE (UNII: FW23481S7S)
HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)
SODIUM SULFATE (UNII: 0YPR65R21J)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MORUS NIGRA LEAF (UNII: 9354SX710I)
WINE GRAPE (UNII: 3GOV20705G)
ELEUTHERO (UNII: ZQH6VH092Z)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
RASPBERRY (UNII: 4N14V5R27W)
PLUM (UNII: 67M3EQ6BE1)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81230-001-02	1 in 1 CARTON	12/09/2020	12/31/2022
1	NDC: 81230-001-01	150 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/09/2020	12/31/2022

Labeler - INWARD. Co.,Ltd. (695703051)

Registrant - INWARD. Co.,Ltd. (695703051)

Establishment
Name	Address	ID/FEI	Business Operations
Woosin Cosmetics Co., Ltd.		688227829	manufacture(81230-001)

Revised: 7/2023

Document Id: 00eef109-aacc-569d-e063-6394a90a6986

34390-5

Set id: d5b028cb-8421-479a-9861-de7cd12194dc

Version: 4

Effective Time: 20230720