Label: SKYLAKE ORIENTAL HERB EYE- witch hazel cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53798-010-01 - Packager: SKYLAKE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 20, 2012
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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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
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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
- INDICATIONS AND USAGE
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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
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INGREDIENTS AND APPEARANCE
SKYLAKE ORIENTAL HERB EYE
witch hazel creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53798-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.02 g in 20 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) glycerin (UNII: PDC6A3C0OX) butylene glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53798-010-01 20 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2012 Labeler - SKYLAKE (688226324) Registrant - SKYLAKE (688226324) Establishment Name Address ID/FEI Business Operations SKYLAKE 688226324 manufacture(53798-010)
