HAISHEN 80 SEA CUCUMBER NUTRITIVE FRESH- dimethicone cream 
JUNGLEFOOD 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: DIMETHICONE 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: SEA CUCUMBER EXTRACT, WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERETH-26, NIACINAMIDE, GLYCERIN, HYDROXYPROPYL STARCH PHOSPHATE, GLYCERYL CAPRYLATE, SWIFTLET NEST EXTRACT, CYCLOHEXASILOXANE, CARBOMER, TRIETHANOLAMINE, DIMETHICONOL, GLYCERYL STEARATE, CHLORPHENESIN, PEG-150 DISTEARATE, PERFUME, BUTYLENE GLYCOL, GLYCERYL POLYACRYLATE, POLYSORBATE 80, VP/EICOSENE COPOLYMER, CETEARYL ALCOHOL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ADENOSINE, DISODIUM EDTA, SODIUM HYALURONATE, ALLANTOIN, CAVIAR EXTRACT

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: Apply smoothly on the entire face in the morning and night.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HAISHEN 80 SEA CUCUMBER NUTRITIVE FRESH 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70603-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.8 g  in 80 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70603-010-021 in 1 CARTON03/02/2016
1NDC:70603-010-0180 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/02/2016
Labeler - JUNGLEFOOD CO., LTD. (689605638)
Registrant - JUNGLEFOOD CO., LTD. (689605638)
Establishment
NameAddressID/FEIBusiness Operations
JUNGLEFOOD CO., LTD.689605638manufacture(70603-010)

Revised: 4/2016
Document Id: a9a627f8-8f49-4ace-95da-a868ef6cd1dd
Set id: 32848497-6793-4279-b8c8-6b036a3e41ff
Version: 1
Effective Time: 20160408
 
JUNGLEFOOD CO., LTD.