TONYMOLY PANDAS DREAM WHITE HAND CREAM- 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 Ingredients

Glycerin 7.00%, Dimethicone 0.50%

Purpose

Skin Protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin.

Warnings

For external use only.

Do not use

Stop use and ask a doctor if

When using this product

Keep out of reach of children

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

Directions

Apply as needed.

Inactive Ingredients

Water, Butyrospermum Parkii (Shea) Butter, Cetyl Ethylhexanoate, Cetearyl Alcohol, Butylene Glycol, Niacinamide, Glyceryl Stearate, Polysorbate 60, PEG/PPG-17/6 Copolymer, Cyclopentasiloxane, Hydrogenated Polydecene, Beeswax, Cyclohexasiloxane, Palmitic Acid, Stearic Acid, Xanthan Gum, PEG-100 Stearate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Polyacrylate-13, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Sorbitan Stearate, Caprylyl Glycol, Honey Extract, Phyllostachis Bambusoides Juice, Sorbitan Isostearate, Polysorbate 20, Disodium EDTA, Alcohol, Polyglutamic Acid, Citric Acid

Questions?

Call 1-848-200-2230

Package Label

panda dream white hand cream

TONYMOLY PANDAS DREAM WHITE HAND CREAM 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.15 g  in 30 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.1 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SHEA BUTTER (UNII: K49155WL9Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HONEY (UNII: Y9H1V576FH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYGALIC ACID (UNII: XCC6WEA55L)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ALCOHOL (UNII: 3K9958V90M)  
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-152-011 in 1 BOX01/19/2016
130 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/14/2016
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca688830827manufacture(59078-152)

Revised: 2/2016
Document Id: 2b85f5e8-aabe-44e1-e054-00144ff8d46c
Set id: 2b85f5e8-aabd-44e1-e054-00144ff8d46c
Version: 1
Effective Time: 20160211
 
Tonymoly Co., Ltd.