Label: KARL AND HANS BOTANIC JASMINE- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 78151-020-01, 78151-020-02
- Packager: PIGEON CORPORATION
- 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 May 25, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
D-Sorbitol Solution, Concentrated Glycerin, Water, Silicon Dioxide, Sodium Lauryl Sulfate, Jasmine Flavor, Xylitol, Sodium Carboxymethylcellulose, Enzymatically Modified Stevia, Jasmine Mint Flavor, Titanium Oxide, Spearmint Oil, Aluminium Chlorohydroxy Allantoinate, Hydroxyapatite, L-Menthol, Propolis Extract10, Matricaria Extract, Green Tea Extract, Aloe Extract, Rosemary Extract, Grapefruit Extract, Taraxacum, officinale Extract, Clove extract, Moutan Root 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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KARL AND HANS BOTANIC JASMINE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78151-020 Route of Administration TOPICAL 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) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78151-020-02 1 in 1 CARTON 05/01/2022 1 NDC:78151-020-01 100 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 05/01/2022 Labeler - PIGEON CORPORATION (687877613) Registrant - PIGEON CORPORATION (687877613) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(78151-020)
