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Esopinio Topaz Phyto

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 0.91g in 120g
Labeler: ZION SYNTHETIC FIBER CO., LTD.
NDC Code: 44781-230

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.

ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.76%

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

Purpose:
1. Cavity Protection
2. Anti-plaque
3. Whitens Teeth
4. Breath Freshening

WARNINGS

Warnings:
If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center iimmediately. Children under 2 years, ask a dentist or physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

INDICATIONS AND USAGE

Indications and usage:
1. Brush teeth thoroughly, preferably after each meal, or at least twice a day,
2. Keep the lid tightly closed after using.
3. Keep at a room temperature

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

ESOPINIO TOPAZ PHYTO 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-230
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (FLUORIDE ION) FLUORIDE ION0.91 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Titanium Dioxide 
Water 
Packaging
#Item CodePackage Description
1NDC:44781-230-01120 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2013
Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Establishment
NameAddressID/FEIOperations
ZION SYNTHETIC FIBER CO., LTD.688011147manufacture(44781-230)

Revised: 08/2013
 
ZION SYNTHETIC FIBER CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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