TANGERINE HAND: Package Insert and Label Information

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.

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

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TANGERINE HAND
glycerin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-053
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Glycerin (GLYCERIN) Glycerin 6 g in 30 g
Inactive Ingredients
Ingredient Name Strength
Water
Arbutin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59078-053-01 30 g in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/01/2014
Labeler — TONYMOLY CO., LTD. (688216798)
Registrant — TONYMOLY CO., LTD. (688216798)
Establishment
Name Address ID/FEI Operations
TONYMOLY CO., LTD. 688216798 repack (59078-053)
Establishment
Name Address ID/FEI Operations
PICOSTECH CO., LTD. 557816754 manufacture (59078-053)

Revised: 03/2015 TONYMOLY CO., LTD.

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