PLU REFRESH PEELING FACIAL SCRUB- glycerin scrub lotion 
Zivon Cosmetic Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Glycerin (2.0%) - Skin Protectant
Allantoin (0.1%) - Skin Protectant

INACTIVE INGREDIENT

Water, Butylene Glycol, Cellulose, Alcohol, PEG-40 Hydrogenated Caster Oil, Carbormer, Allantoin, Ananas Sativus (Pineapple) Fruit Extract, Lavandula Angustifolia (Lavender) Extract, Origanum Vulgare Leaf Extract, Rosmarinus Officinalis (Rosemary) Extract, Thymus Vulgaris (Thyme) Extract, Prunus Persica (Peach) Fruit Extract, Aloe Barbadensis Leaf Juice, Tromethamine, Phenoxyethanol, Fragrance

PURPOSE

Skin Protectact

WARNINGS

The safety of this product has not been determined.
1. Stop using of this product if any below symptom is found. Continuous use may worsen the symptom. Please contact dermatologist. a. In case of any troubles, such as red spots, swollen skin, itchy or irritation. b. In case of any trouble on applied area as above due to direct light.
2. Do not apply on trouble area such as wound, eczema or dermatitis.
3. Cautions for storage and handling a. After use, make sure to close cap. b. Keep away from reach of children. c. Do not keep in area where temperature is too hight or too low and avoid direct light.
4. Do not use other than product's specified application.
5. In case of use for baby or children, be careful not to rub eyes or put into mouth.
6. Excessive rubbing may cause wound.
7. Adjust application frequency by type of skin.
8. In use, be careful not have scrub particles get into eyes.
9. When particle gets into eyes, do not rub but wash out with water. If particle resides in eyes, please consult with medical doctor.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Dry Skin. Apply scrub on face and gently massage except eye area and rinse thoroughly with lukewarm water.

DOSAGE & ADMINISTRATION

Dry Skin. Apply scrub on face and gently massage except eye area and rinse thoroughly with lukewarm water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

PLU REFRESH PEELING FACIAL SCRUB 
glycerin scrub lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71503-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin2 g  in 100 mL
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Alcohol (UNII: 3K9958V90M)  
Tromethamine (UNII: 023C2WHX2V)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71503-001-01100 mL in 1 PACKAGE; Type 0: Not a Combination Product06/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/26/2017
Labeler - Zivon Cosmetic Co., Ltd. (693893738)
Registrant - Zivon Cosmetic Co., Ltd. (693893738)
Establishment
NameAddressID/FEIBusiness Operations
Zivon Cosmetic Co., Ltd.693893738manufacture(71503-001)

Revised: 6/2017
Document Id: 22f48b77-9bfa-4bd6-9a8c-07525e386874
Set id: c92187eb-7d0e-4bd8-929e-91485a7c9f10
Version: 1
Effective Time: 20170626
 
Zivon Cosmetic Co., Ltd.