TANGERINE HAND- glycerin cream 
TONYMOLY CO., LTD.

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 Ingredient: Glycerin 20%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Vegetable Oil, Cyclopentasiloxane, Cyclohexasiloxane, Caprylic/Capric Triglyceride, Tribehenin PEG-20 Esters, Octyldodecanol, Citrus Aurantium Dulcis (Orange) Fruit Extract (2%)&Butylene Glycol (5%)& Water(93%), Butyrospermum Parkii(Shea Butter), Arbutin, Dipropylene Glycol, Citrus Medica Limonum (Lemon) Fruit Extract(2%) & Butylene Glycol(5%)&Water(93%), Dimethicone, Citrus Junos Fruit Extract(2%)& Propylene Glycol(10%) & Water(88%), Glyceryl Stearate, Fragrance, Phenoxyethanol, Methylparaben, Propylparaben, Xanthan Gum, Carbomer, Triethanolamine, CI 19140, CI 17200

PURPOSE

PURPOSE: Skin Protectant

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 into 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 & USAGE

INDICATIONS AND USAGE: Clean the hands, remove moist, apply sufficient amount on the hands. Could use on elbows and knees.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

Image of carton

TANGERINE HAND 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin6 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Arbutin (UNII: C5INA23HXF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-053-0130 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2014
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798repack(59078-053)
Establishment
NameAddressID/FEIBusiness Operations
PICOSTECH CO., LTD.557816754manufacture(59078-053)

Revised: 3/2015
Document Id: e2669d43-fc9b-4714-82ea-391d4773e626
Set id: 8427de4d-7883-4cdc-b048-5474a06ace23
Version: 1
Effective Time: 20150306
 
TONYMOLY CO., LTD.