Label: UNPA CHA CHA TOOTHPASTE- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 73134-040-01, 73134-040-02 - Packager: Lycl Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 23, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Sorbitol, Water, Silica, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Mint Flavor, Carbon, Mentha Piperita (Peppermint) Oil, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract
- PURPOSE
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WARNINGS
■ Contains 977ppm 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
- Uses
- Directions
- Other Information
- Questions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNPA CHA CHA TOOTHPASTE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73134-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.74 g in 100 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73134-040-02 1 in 1 CARTON 02/01/2021 1 NDC:73134-040-01 100 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 02/01/2021 Labeler - Lycl Inc. (689062275) Registrant - Lycl Inc. (689062275) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(73134-040)
