Label: PURE HYDROGEL APPLE ZONE- glycerin patch
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Contains inactivated NDC Code(s)
NDC Code(s): 58474-020-01 - Packager: WOOIL C&TECH.CORP
- 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 May 23, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Ceratonia Siliqua Gum, Butylene Glycol, Dipotassium Glycyrrhizate, Adenosine, Galactomyces Ferment Filtrate, Bifida Ferment Lysate,Rosmarinus Officinalis (Rosemary) Leaf Extract, Lavandula Angustifolia(Lavender) Extract, Jasminum Officinale (jasmine) Extract,
Verbena Officinalis Extract, Allantoin, Chondrus Crispus(Carrageenan), Xanthan Gum, Mannan, Potassium Alginate, Sodium Anisate, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Fragrance - PURPOSE
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WARNINGS
Warnings:
1. In case of having following symptoms after using this, your re' advised to stop using it immediately. If you keep using the symptoms will get worse and need to consult a dermatologist.
1)In case of having problem such as red rash, swollenness, itching, stimulation during usage.
2)In cace 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 hae a scar, eczema, or dermatitits.
3. In case of getting it into your eyes, you have to wash it immediately
4. Keep out of reach of babies and children
5. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct - KEEP OUT OF REACH OF CHILDREN
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INDICATIONS AND USAGE
Indications and usage:
1. After cleansing the face, smooth the skin using a toner, then remove film on both sides of hydro-gel mask.
2. Apply and gently press the upper mask on your face considering the position of eyes, lower mask on your face considering the position of mouth.
3. Rest comfortably for 20-30 minutes and removed the mask. -
DOSAGE AND ADMINISTRATION
Dosage and administration:
1. After cleansing the face, smooth the skin using a toner, then remove film on both sides of hydro-gel mask.
2. Apply and gently press the upper mask on your face considering the position of eyes, lower mask on your face considering the position of mouth.
3. Rest comfortably for 20-30 minutes and removed the mask. - PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURE HYDROGEL APPLE ZONE
glycerin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58474-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin 7.5 g in 30 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Adenosine (UNII: K72T3FS567) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58474-020-01 30 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2013 Labeler - WOOIL C&TECH.CORP (688331078) Registrant - WOOIL C&TECH.CORP (688331078) Establishment Name Address ID/FEI Business Operations WOOIL C&TECH.CORP 688331078 manufacture(58474-020)
