Sallys Box Secret Garden Tea Tree Oil Ampoule Mask by Imine Co., Ltd 59401-013_Deactivation

Sallys Box Secret Garden Tea Tree Oil Ampoule Mask by

Drug Labeling and Warnings

Sallys Box Secret Garden Tea Tree 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 TEA TREE OIL AMPOULE MASK- 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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59401-013_Deactivation

Allantoin (0.02%)

Moisturizing + Relaxing + Anti-trouble

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

The product contains salicylic acid and the sodium content. Do not use in children under 3 years of age.

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, Alcohol, PEG-75, Citrus Paradisi (Grapefruit) Fruit Extract, Betaine, Melaleuca Alternifolia (Tea Tree) Leaf Extract, PEG-60 Hydrogenated Castor Oil, Panthenol, Carbomer, Potassium Hydroxide, Ethylhexylglycerin, Salicylic Acid, Portulaca Grandiflora Extract , Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Extract , Chamomilla Recutita (Matricaria) Flower Extract , Camellia Sinensis Leaf Extract , Paeonia Albiflora Root Extract , Jasminum Officinale (Jasmine) Extract , Mentha Viridis (Spearmint) Extract , Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Melaleuca Alternifolia (Tea Tree) Leaf Oil , Disodium EDTA, Phenoxyethanol, Fragrance
<Step 2> Water, Butylene Glycol, Glycerin, PEG/PPG-17/6 Copolymer, Alcohol, PEG-75, Citrus Paradisi (Grapefruit) Fruit Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Panthenol, PEG-60 Hydrogenated Castor Oil, Carbomer, Potasium Hydroxide, Ethylhexylglycerin, Allantoin, Portulaca Grandiflora Extract , Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Extract , Chamomilla Recutita (Matricaria) Flower Extract , Camellia Sinensis Leaf Extract , Paeonia Albiflora Root Extract , Jasminum Officinale (Jasmine) Extract , Mentha Viridis (Spearmint) Extract , Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Melaleuca Alternifolia (Tea Tree) Leaf Oil , Disodium EDTA, Phenoxyethanol, Fragrance

Tea Tree Oil

SALLYS BOX SECRET GARDEN TEA TREE OIL AMPOULE MASK 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59401-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0042 mg  in 21 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
GRAPEFRUIT (UNII: O82C39RR8C)  
BETAINE (UNII: 3SCV180C9W)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
PANTHENOL (UNII: WV9CM0O67Z)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
PORTULACA GRANDIFLORA SEED (UNII: 73NV03RHQT)  
ROSEMARY (UNII: IJ67X351P9)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CHAMOMILE (UNII: FGL3685T2X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
MENTHA SPICATA (UNII: O2H83I4PUN)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59401-013-0121 mL in 1 POUCH; Type 0: Not a Combination Product11/25/201412/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/25/201412/27/2019
Labeler - Imine Co., Ltd (557816813)
Registrant - Imine Co., Ltd (557816813)
Establishment
NameAddressID/FEIBusiness Operations
i Mine Co.,Ltd.557816813manufacture(59401-013)

Revised: 12/2019
 
Imine Co., Ltd