Sallys Box Secret Garden Lemon Oil Ampoule Mask by Imine Co., Ltd 59401-010_Deactivation

Sallys Box Secret Garden Lemon Oil Ampoule Mask by

Drug Labeling and Warnings

Sallys Box Secret Garden Lemon Oil Ampoule Mask by is a Otc medication manufactured, distributed, or labeled by Imine Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALLYS BOX SECRET GARDEN LEMON OIL AMPOULE MASK- niacinamide, allantoin cream 
Imine 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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59401-010_Deactivation

Niacinamide (0.5%)

Allantoin (0.02%)

Moisturizing + Soothing + Luminous

Use with caution if you are highly sensitive to any bandages or wet compresses.

Apply one mask sheet at a time.

Skin Protectant

1. After cleansing your face, apply step 1-ampoule serum to face. 2 Before step 1- ampoule serum is completely absorbed, take the step2-mask sheet out from the package and attach it evenly over your face avoiding the eye and mouth area. 3. Remove it after 10-20 minutes. Using your fingers, gently pat any remaining essence into the skin until thoroughly absorbed.

Keep out of reach of children.

If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above.

Avoid contact with eyes. In case of contact with eyes, rinse immediately with water.

Do not use the product on an open skin wound or on areas of eczema or infection.

<Step 1> Water, Butylene Glycol, Glycerin, PEG/PPG-17/6 Copolymer, Diethoxyethyl Succinate, Trehalose, Citrus Paradisi (Grapefruit) Fruit Extract, Alcohol, Citrus Medica Limonum (Lemon) Fruit Extract, Panthenol, Polyacrylic Acid, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-60 Hydrogenated Castor Oil, Betaine, Potassium Hydroxide, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Viridis (Spearmint) Extract, Paeonia Albiflora Root Extract, Jasminum Officinale (Jasmine) Extract, Portulaca Grandiflora Extract , Chamomilla Recutita (Matricaria) Flower Extract, Mentha Piperita (Peppermint) Leaf Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Citrus Limon (Lemon) Peel Oil, Disodium EDTA, Phenoxyethanol, Fragrance
<Step 2> Water, Butylene Glycol, Glycerin, PEG/PPG-17/6 Copolymer, Alcohol, PEG-75, Citrus Paradisi (Grapefruit) Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Panthenol, PEG-60 Hydrogenated Castor Oil, Carbomer, Potassium Hydroxide, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Viridis (Spearmint) Extract, Paeonia Albiflora Root Extract, Jasminum Officinale (Jasmine) Extract, Portulaca Grandiflora Extract , Chamomilla Recutita (Matricaria) Flower Extract, Mentha Piperita (Peppermint) Leaf Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Citrus Limon (Lemon) Peel Oil, Disodium EDTA, Phenoxyethanol, Fragrance

SALLYS BOX SECRET GARDEN LEMON OIL AMPOULE MASK 
niacinamide, allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59401-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.0042 mg  in 21 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.105 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
DIETHOXYETHYL SUCCINATE (UNII: R1B8ZV94R9)
TREHALOSE (UNII: B8WCK70T7I)
GRAPEFRUIT (UNII: O82C39RR8C)
ALCOHOL (UNII: 3K9958V90M)
LEMON (UNII: 24RS0A988O)
PANTHENOL (UNII: WV9CM0O67Z)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
BETAINE (UNII: 3SCV180C9W)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
ROSEMARY (UNII: IJ67X351P9)
MENTHA SPICATA (UNII: O2H83I4PUN)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
PORTULACA GRANDIFLORA WHOLE (UNII: 58DNV0B13N)
CHAMOMILE (UNII: FGL3685T2X)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LEMON OIL (UNII: I9GRO824LL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59401-010-01	21 mL in 1 POUCH; Type 0: Not a Combination Product	11/19/2014	12/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/19/2014	12/26/2019

Labeler - Imine Co., Ltd (557816813)

Registrant - Imine Co., Ltd (557816813)

Establishment
Name	Address	ID/FEI	Business Operations
i Mine Co.,Ltd.		557816813	manufacture(59401-010)

Revised: 12/2019

Document Id: 9aa427c4-bcb9-6b6f-e053-2a95a90a15e8

34390-5

Set id: 7d22fa79-a4c5-4554-97a7-6b09863cd940

Version: 2

Effective Time: 20191226

 

Imine Co., Ltd