Label: ESOPINIO TOPAZ PHYTO- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 44781-230-01 - Packager: ZION SYNTHETIC FIBER CO., LTD.
- 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 August 16, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Dicalcium Phosphodihydrate, Tocopheryl Acetate, Sodium Benzoate, d-Sorbitol, Sodium, Carboxymethylcellulose, Silica, Monosodium Phosphate, Sodium Lauryl Sulfate, Sorbitan, Monooleate, Tetrasodium Phyrophosphate, Sodium Saccharin, Xylitol, Mentha (peppermint)
Leaf Extract, Fragrance, Salvia Officinalis (Sage) Leaf Extract, Commiphora Myrrha Extract, Cardamom Extract, Chamomilla Recutita (Matricaria) Flower Extract, Blue l, Yellow 5, Titanium Dioxide, Composite Topaz (MM-1), Water - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
Dosage and Administration:
1. Children 2 to 6 years of age: To minimize swallowing, use only a pea sized amount and supervise child's brushing until good habits are established.
2. Children under 2 years: Ask your dentist or physician.
3. Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal, or at least twice a day. - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ESOPINIO TOPAZ PHYTO
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44781-230 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 Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44781-230-01 120 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2013 Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147) Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147) Establishment Name Address ID/FEI Business Operations ZION SYNTHETIC FIBER CO., LTD. 688011147 manufacture(44781-230)