ESCOPINIO PHYTO ALPHA TOOTHPASTE - sodium monofluorophosphate paste 
Zion Synthetic Fiber Corporation Limited

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.

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Active Ingredients: Sodium Monofluorophosphate

Other Ingredients:
Water, Dicalcium Phosphodihydrate, Tocopheryl Acetate, Sodium Benzoate, d-Sorbitol, Sodium Carboxymethylcellulose, Silica, Monosodium Phosphate, Sodium Lauryl Sulfate, Monooleic Sorbate, Tetrasodium Pyrophosphate, Sodum Saccharin, Xylitol, Mentha (peppermint), Fragrance HF 30302, Sage Oil, Myrrh Extract, Cardamom Extract, Blue FCF #1, Yellow #4, Titanium Dioxide

Directions:
Adults and children 2 years and older:
Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by your dentist.

Children under 6 years of age:
To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.

Children under 2 years: Ask a dentist or physician

Care and Handling:
Keep the lid tightly closed after using.
Keep at a room temperature

BOX LABEL
ESCOPINIO PHYTO ALPHA TOOTHPASTE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-447
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.912 g  in 120 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44781-447-81120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/21/2010
Labeler - Zion Synthetic Fiber Corporation Limited (688011147)
Registrant - Zion Synthetic Fiber Corporation Limited (688011147)
Establishment
NameAddressID/FEIBusiness Operations
Zion Synthetic Fiber Corporation Limited688011147manufacture

Revised: 1/2010
Document Id: 2e7c2d4f-ea08-4398-affe-2548560fa48d
Set id: 491a242f-7c80-464d-82f6-52ecf8d56e82
Version: 1
Effective Time: 20100121
 
Zion Synthetic Fiber Corporation Limited