Label: NEED FOR YOU LIMPIO TOOTH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 81373-010-01, 81373-010-02 - Packager: NEED FOR YOU
- Category: HUMAN OTC DRUG LABEL
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 December 30, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Sorbitol, Water, Sodium Cocoyl Glutamate, Cellulose Gum, Glycerin, Menthol, Mentha Piperita (Peppermint) Oil, Mentha Spicata Herb Oil, Herb Flavor, Stevioside, Hydroxyapatite, Xylitol, Citrus Grandis (Grapefruit) Seed Extract, Propolis Wax, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Eucalyptus Globulus Leaf Extract, Aloe Barbadensis Leaf Extract, Taraxacum Officinale (Dandelion) Rhizome, Ascorbic Acid
- PURPOSE
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WARNINGS
■ Contains 1000ppm of fluoride.
■ Do not swallow and rinse mouth thoroughly after use
■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
■ Keep out of the reach of children under 6 years of age. - KEEP OUT OF REACH OF CHILDREN
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Uses
■ Keep your teeth white and strong.
■ Keep your mouth clean.
■ Refresh the inside of the mouth.
■ Prevents tooth decay caused by fluoride and removes bad breath.
■ Increases aesthetic effect.
■ Prevention of gingivitis and periodontitis (alveolar fistula)
■ Prevention of periodontal disease
■ Prevention of gum disease
■ Prevention of plaque deposition, removal of plaque (anti-prag) - Directions
- Other Information
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEED FOR YOU LIMPIO TOOTH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81373-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.91 g in 120 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81373-010-02 1 in 1 CARTON 12/01/2020 1 NDC:81373-010-01 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/01/2020 Labeler - NEED FOR YOU (695126264) Registrant - NEED FOR YOU (695126264) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD 557810721 manufacture(81373-010)
