NATORAL KOREAN GINSENG- menthol mouthwash 
Natoral Limited

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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Drug Facts

Menthol 0.03%

Antigingivitis

Helps control plaque that leads to gingivitis.

Adults and children 12 years of age and older Vigorously swish 20mL (2/3 FL OZ or 4 teaspoonful) between teeth for 30 seconds then spit out; do not swallow
Children under 12 years of age Consult a dentist or doctor
Children under 6 years Do not use unless directed by a dentist or a physician

Do not give to children under 12 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Water, Glycerin, PEG-60 Hydrogenated Castor Oil, Propolis Extract, Citric Acid, Sodium Benzoate, Camellia Sinensis Leaf Extract, Xylitol, Panax Ginseng Root Extract, Flavor, Sodium Citrate, Caramel, Malic Acid, Sodium Saccharin

12 mL Sachet x 6

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260 mL Bottle

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520 mL Bottle

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NATORAL KOREAN GINSENG 
menthol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71211-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
XYLITOL (UNII: VCQ006KQ1E)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
CARAMEL (UNII: T9D99G2B1R)  
MALIC ACID (UNII: 817L1N4CKP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71211-001-026 in 1 BOX01/29/2017
1NDC:71211-001-0112 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:71211-001-03260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/29/2017
3NDC:71211-001-04520 mL in 1 BOTTLE; Type 0: Not a Combination Product01/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/29/2017
Labeler - Natoral Limited (664445977)
Registrant - Natoral Limited (664445977)
Establishment
NameAddressID/FEIBusiness Operations
LCC Ltd688785286manufacture(71211-001)

Revised: 2/2017
Document Id: 4787fda6-ded2-0ac1-e054-00144ff8d46c
Set id: 9ea0315f-a581-4913-854c-3731816b87ea
Version: 1
Effective Time: 20170202
 
Natoral Limited