SKEDERM LIFTING by Skederm Inc. / Kovas Co., Ltd. 70209-004_Deactivation

SKEDERM LIFTING by

Drug Labeling and Warnings

SKEDERM LIFTING by is a Otc medication manufactured, distributed, or labeled by Skederm Inc., Kovas Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKEDERM LIFTING- glycerin patch 
Skederm Inc.

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.

----------

70209-004_Deactivation

GLYCERIN 30%

Skin Protectant

Facial litfing and moisturizing

1. Clean your face before using the mask.

2. Hang the mask on the both ears and press gently to make it fit your cheek and chin.

3. Leave on the face for 20~30 mins or extent the usage time if you wish but no longer than 1 hour.

Use 2 or 3 times a week

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

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

Water
Sodium Polyacrylate
Dipropylene Glycol
Agar
Polyacrylic Acid
Phenoxyethanol
Disodium EDTA
Tartaric Acid
Adenosine
Aluminum Glycinate
Silica
Cetyl Ethylhexanoate
Isomerized Safflower Acid
Aloe Barbadensis Leaf Juice
Caffeine
Betaine
Butylene Glycol
Hydrolyzed Collagen

SKEDERM LIFTING 
glycerin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70209-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.1 g  in 7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
AGAR (UNII: 89T13OHQ2B)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TARTARIC ACID (UNII: W4888I119H)
ADENOSINE (UNII: K72T3FS567)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAFFEINE (UNII: 3G6A5W338E)
BETAINE (UNII: 3SCV180C9W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70209-004-02	5 in 1 PACKAGE	01/30/2018	01/28/2020
1	NDC: 70209-004-01	7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/30/2018	01/28/2020

Labeler - Skederm Inc. (079981781)

Registrant - Skederm Inc. (079981781)

Establishment
Name	Address	ID/FEI	Business Operations
Kovas Co., Ltd.		688783559	manufacture(70209-004)

Revised: 1/2020

Document Id: 9d3bd69e-18b5-d1f7-e053-2995a90a7eb2

34390-5

Set id: 497b58be-0fe8-4360-9210-0432a0c6860e

Version: 4

Effective Time: 20200128

 

Skederm Inc.