NATORAL KOREAN GINSENG- menthol mouthwash

Natoral Korean Ginseng by

Drug Labeling and Warnings

Natoral Korean Ginseng by is a Otc medication manufactured, distributed, or labeled by Natoral Limited, LCC Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 0.03%

PURPOSE

Antigingivitis

INDICATIONS & USAGE

Helps control plaque that leads to gingivitis.

DOSAGE & ADMINISTRATION

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

• This rinse is not intended to replace brushing or flossing.

WARNINGS

• Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease. Do not give to children under 12 years of age.

• Stop Use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks.

KEEP OUT OF REACH OF CHILDREN

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

12 mL Sachet x 6

PRINCIPAL DISPLAY PANEL

260 mL Bottle

PRINCIPAL DISPLAY PANEL

520 mL Bottle

INGREDIENTS AND APPEARANCE

NATORAL KOREAN GINSENG 
menthol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71211-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71211-001-02	6 in 1 BOX	01/29/2017
1	NDC: 71211-001-01	12 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71211-001-03	260 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2017
3	NDC: 71211-001-04	520 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/29/2017

Labeler - Natoral Limited (664445977)

Registrant - Natoral Limited (664445977)

Establishment
Name	Address	ID/FEI	Business Operations
LCC Ltd		688785286	manufacture(71211-001)