A.H.C COTTON 100 MASK SKIN CERAMIDE

Drug Labeling and Warnings

Drug Details [pdf]

A.H.C COTTON 100 MASK SKIN CERAMIDE- niacinamide, allantoin, adenosine patch 
Carver Korea Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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A.H.C COTTON 100 MASK SKIN CERAMIDE

Active ingredients

Niacinamide (2%)

Allantoin (0.1%)

Adenosine (0.04%)

Purpose

Skin protectant

Uses

Moisturizes skin. Wrinkle and brightening care.

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this produdct

- Avoid contact with eyes. If contact occurs, rinse eyes toroughly with water.

- Do not apply directly to wound or open cut.

Stop use and ask a doctor if rash or irritation on skin developes and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

1) After cleansing face, apply toner

2) Open the pouch, put the mask on face.

3) After 10-20 minutes, remove the mask, and pat lightly until the rest of essence to be absorbed to skin.

Inactive ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Butylene Glycol, Cyclopentasiloxane, Cetearyl Alcohol, Glyceryl Stearate, Methylpropanediol, Hydroxyacetophenone, Cyclohexasiloxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caffeine, Dimethiconol, Tromethamine, Xanthan Gum, Mesembryanthemum Crystallinum Extract, Caprylyl Glycol, Ethylhexylglycerin, Fragrance(Parfum), Disodium EDTA, Pentylene Glycol, Trehalose, Sea Water, Hydrogenated Lecithin, 1,2-Hexanediol, Ceramide NP, Aloe Barbadensis Leaf Extract, Urea, Dipropylene Glycol, Althaea Rosea Flower Extract, Sodium Palmitoyl Proline, Dimethicone/Vinyl Dimethicone Crosspolymer, Macadamia Ternifolia Seed Oil, Lecithin, Nymphaea Alba Flower Extract, Polyglutamic Acid, Saccharide Isomerate, Sodium Hyaluronate, Sphingolipids, Sucrose Distearate, Nelumbo Nucifera Flower Extract, Cholesterol, Creatine, Phytosphingosine, Prunus Mume Fruit Extract, Oleic Acid, Vinegar, Lavandula Angustifolia (Lavender) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Saccharomyces Ferment Filtrate, Sodium Ascorbyl Phosphate, Chamaecyparis Obtusa Leaf Extract, Origanum Vulgare Leaf Extract, Propolis Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Scutellaria Baicalensis Root Extract, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A.H.C COTTON 100 MASK SKIN CERAMIDE 
niacinamide, allantoin, adenosine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.025 g  in 25 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.05 g  in 25 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.01 g  in 25 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CAFFEINE (UNII: 3G6A5W338E)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TROMETHAMINE (UNII: 023C2WHX2V)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CERAMIDE NP (UNII: 4370DF050B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MACADAMIA OIL (UNII: 515610SU8C)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CREATINE (UNII: MU72812GK0)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
OLEIC ACID (UNII: 2UMI9U37CP)
ACETIC ACID (UNII: Q40Q9N063P)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
ROSEMARY (UNII: IJ67X351P9)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
OREGANO (UNII: 0E5AT8T16U)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SALIX ALBA BARK (UNII: 205MXS71H7)
CHINESE CINNAMON (UNII: WS4CQ062KM)
PURSLANE (UNII: M6S840WXG5)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
UREA (UNII: 8W8T17847W)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-105-02	10 in 1 PACKAGE	09/05/2017	12/01/2018
1	NDC: 58930-105-01	25 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/05/2017	12/01/2018

Labeler - Carver Korea Co.,Ltd. (688442290)

Registrant - Carver Korea Co.,Ltd. (688442290)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(58930-105)

Revised: 5/2019

Document Id: 3f0f3383-6d35-4f93-acdf-d474a40490a1

34390-5

Set id: 57edbea4-f902-496e-e053-2a91aa0a2c0e

Version: 3

Effective Time: 20190515