SKYLAKE ORIENTAL HERB EYE- witch hazel cream 
SKYLAKE

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.

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ACTIVE INGREDIENT

Active ingredients: Witch Hazel 0.1%

INACTIVE INGREDIENT

Inactive ingredient lists:
water, angelica gigas extract, peppermint leaf extract, artemisia absinthium extract, Morus Alba Leaf Extract, cnidium officinale root extract, glycyrrhiza glabra (licorice) root extract, morus alba bark extract, artemisia absinthium extract, angelica dahurica root extract, scutellaria baicalensis root extract, pueraria lobata root extract, inula helenium extract, laminaria japonica extract, phellodendron amurense bark extract, clove flower extract, apricot kernel oil, jojoba oil, evening primrose oil, Camellia Japonica Seed Oil, rosa canina fruit oil, grape seed oil, shea butter, beeswax, sorbitan olivate, Ceramide1, scutellaria baicalensis root extract, Paeonia Suffruticosa Root Extract, glycerin, butylene glycol, hyaluronic acid, vitaminE, Propolis Extract, Bitter Orange Flower Extract(Neroli), Rose Flower Oil, Silk extract

PURPOSE

Purpose: Skin Protectant, Moisturize

WARNINGS

Warnings:
1. In case of having following symptoms after using this. you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it in your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
Keep out of reach of babies and children

INDICATIONS AND USAGE

Indication and usage:
1. Tighten the lid after using it.
2. Don't keep it in the place where temperature extremely hot or low and exposed to the direct sunlight.
3. Use it anytime.

DOSAGE AND ADMINISTRATION

Dosage and administration:
- The use of silk extract containing ‘Resveratrol’ known for enhancing antioxidant and anti-inflammatory activities and skin elasticity keeps skin healthy and elastic.
- A patented SKYLAKE herbal extract (No. 0566933) offers excellent calming and moisturizing effects to irritated skin.
- The uses of natural ingredients such as natural preservative, bee wax and domestic-grown propolis deliver healthy and natural nutrition to skin.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

SKYLAKE ORIENTAL HERB EYE 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53798-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.02 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
butylene glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53798-010-0120 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2012
Labeler - SKYLAKE (688226324)
Registrant - SKYLAKE (688226324)
Establishment
NameAddressID/FEIBusiness Operations
SKYLAKE688226324manufacture(53798-010)

Revised: 12/2012
Document Id: 61e8be8a-abd1-4716-9003-56562b2bba94
Set id: dde10866-04e1-4210-a812-f64a178f6a59
Version: 1
Effective Time: 20121220
 
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