RED SERUM- witch hazel gel 
LAB & Company 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.

----------

Active Ingredient Hamamelis Virginiana (Witch Hazel) Leaf Extract 2.5%

Purpose Skin Protectant

Keep out of reach of children.

Indication and Usage

Apply to the entire face and neck after face wash and toner. Follow with moisturizer. For both day and night.

Dosage and Administration

Apply 2~4 drops at a time, smoothing in gently.

Warnings

1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist.

1) In case of having problems such as red spots, swelling, itching or irritation during using this product.

2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight.

2. Do not use it on the part where you have a scar, eczema or dermatitis.

3. For external use only.

Inactive Ingredient

water, butylene glycol, glycerin, sodium hyaluronate, betaine, punica granatum fruit extract, vaccinium angustifolium (blueberry) fruit extract, rubus chamaemorus fruit extract, lycium chinense fruit extract, rubus idaeus (raspberry) fruit extract, euterpe oleracea fruit extract, lepidium sativum sprout extract, niacinamide, dioscorea opposita (wild yam) root extract, 1,2-hexanediol, caprylyl glycol, capylhydroxamic acid, boswellia, serrata resin extract, prunus amygdalus dulcis (sweet almond) seed extract, PEG-60 hydrogenated castor oil, allantoin, carbomer, arginine, dipotassium glycyrrhizate, adenosine, jasminum officinale (jasmine) oil, disodium EDTA

image description

RED SERUM 
witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69457-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BETAINE (UNII: 3SCV180C9W)  
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)  
RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)  
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)  
RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)  
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
LEPIDIUM SATIVUM LEAF (UNII: 2ML4POY35W)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIOSCOREA OPPOSITIFOLIA WHOLE (UNII: KZY1A7K8MD)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
ALMOND OIL (UNII: 66YXD4DKO9)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
ARGININE (UNII: 94ZLA3W45F)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ADENOSINE (UNII: K72T3FS567)  
JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69457-000-0040 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/18/2015
Labeler - LAB & Company Inc. (688284779)
Establishment
NameAddressID/FEIBusiness Operations
LAB & Company Inc.688284779manufacture(69457-000)

Revised: 3/2015
Document Id: 4506bc04-758a-4f66-b4a1-27fa2c73ace3
Set id: 0d6098ef-910f-4b2b-a147-e152b1141c72
Version: 1
Effective Time: 20150318
 
LAB & Company Inc.