Label: SPRINJENE NATURAL- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 63404-0201-1 - Packager: Health and Natural Beauty USA Corp
- Category: HUMAN OTC DRUG LABEL
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 January 17, 2017
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
Supervise children as necessary until capable of using without supervision.
Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.
- Inactive Ingredients
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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 99 g Tube Carton
SprinJene®
Naturalwith Fluoride
TOOTHPASTE
with BLACK SEED OIL (Nigella sativa) & ZINC
CAVITY PROTECTION | REMINERALIZES ENAMEL | HELPS DRY MOUTH
NET WT 3.5 OZ (99 g)
Made in USATo accommodate
the needs of
various lifestyles.Certified:
CERTIFIED VEGAN
VEGAN.ORG
VeganGLUTEN-FREE
CERTIFIED
Gluten
FreeU
KosherHALAL
Halal -
INGREDIENTS AND APPEARANCE
SPRINJENE NATURAL
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63404-0201 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Xylitol (UNII: VCQ006KQ1E) Glycerin (UNII: PDC6A3C0OX) Silicon Dioxide (UNII: ETJ7Z6XBU4) Calcium Carbonate (UNII: H0G9379FGK) Acacia (UNII: 5C5403N26O) Propanediol (UNII: 5965N8W85T) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Sodium Bicarbonate (UNII: 8MDF5V39QO) Zinc Citrate (UNII: K72I3DEX9B) Guar Gum (UNII: E89I1637KE) Xanthan Gum (UNII: TTV12P4NEE) Zinc Oxide (UNII: SOI2LOH54Z) Pectin (UNII: 89NA02M4RX) Product Characteristics Color WHITE Score Shape Size Flavor MINT (Minty) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63404-0201-1 1 in 1 CARTON 02/01/2017 1 99 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 02/01/2017 Labeler - Health and Natural Beauty USA Corp (079129688) Establishment Name Address ID/FEI Business Operations Health and Natural Beauty USA Corp 079129688 MANUFACTURE(63404-0201)