BAMBOO SALT 160G- sodium lauryl sulfate paste, dentifrice 
Hanul Trading 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

Sodium Lauryl Sulfate 0.76%

INACTIVE INGREDIENT

Inactive Ingredient: Sorbitol Solution, Water(Aqua), Hydrated Silica, Flavor(Aroma), PEG-6, Xanthan Gum, Cellulose Gum, Poloxamer 407, Sodium Saccharin, Methyl Paraben, Sodium Chloride, Tocopheryl Acetate, Sodium Bisulfite, Camelia Sinensis Leaf Extract, D&C Yellow NO.10(CI47005), FD&C Blue No.1 (CI 42090)

PURPOSE

Purpose: Oral Health Care

WARNINGS

Warnings: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

Direction

Direction: Adults and children 6 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor, Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor

Direction

Direction: Adults and children 6 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor, Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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BAMBOO SALT 160G 
sodium lauryl sulfate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69642-1400
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154) SODIUM LAURYL SULFATE1.21 g  in 160 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69642-1400-21 in 1 CARTON06/10/201506/24/2017
1NDC:69642-1400-1160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/19/2015
Labeler - Hanul Trading Co., Ltd. (689512982)
Registrant - Hanul Trading Co., Ltd. (689512982)
Establishment
NameAddressID/FEIBusiness Operations
KOCO TRADING CO., INC.079457993repack(69642-1400)
Establishment
NameAddressID/FEIBusiness Operations
LG Household&Health Care688276187manufacture(69642-1400)
Establishment
NameAddressID/FEIBusiness Operations
Hanul Trading Co., Ltd.689512982relabel(69642-1400)

Revised: 6/2017
Document Id: 52c1413e-2814-367b-e054-00144ff88e88
Set id: 9d346fda-1da6-4540-93b0-ab9d06e28280
Version: 2
Effective Time: 20170624
 
Hanul Trading Co., Ltd.