Label: NATORAL KOREAN GINSENG- menthol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 71211-001-01, 71211-001-02, 71211-001-03, 71211-001-04 - Packager: Natoral Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 2, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NATORAL KOREAN GINSENG
menthol mouthwashProduct 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)
