Label: SPRINJENE NATURAL SENSITIVITY RELIEF- sodium monofluorophosphate and potassium nitrate paste, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 63404-1942-1 - 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 September 5, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
-
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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 99 g Tube Carton
SprinJene®+Sensitivity
Natural
ReliefCAVITY PROTECTION
TOOTHPASTE
with Black Seed Oil (Nigella sativa) & Zinc
Helps Relieve Teeth Sensitivity | Remineralizes Enamel
Helps Dry Mouth | Cleans Teeth | Freshens BreathNET WT 3.5 OZ (99 g)
Made in USATo accommodate
the needs of
various lifestyles.CERTIFIED VEGAN
V
VEGAN.ORG
VeganGLUTEN-FREE
ICS
CERTIFIED
Gluten
FreeU
KosherHALAL
HalalCertified
-
INGREDIENTS AND APPEARANCE
SPRINJENE NATURAL SENSITIVITY RELIEF
sodium monofluorophosphate and potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63404-1942 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 Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate 50 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Calcium Carbonate (UNII: H0G9379FGK) Silicon Dioxide (UNII: ETJ7Z6XBU4) Propanediol (UNII: 5965N8W85T) Potassium Cocoate (UNII: F8U72V8ZXP) Zinc Citrate (UNII: K72I3DEX9B) Xanthan Gum (UNII: TTV12P4NEE) Acacia (UNII: 5C5403N26O) Zinc Oxide (UNII: SOI2LOH54Z) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63404-1942-1 1 in 1 CARTON 07/01/2017 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 not final part356 07/01/2017 Labeler - Health and Natural Beauty USA Corp (079129688) Establishment Name Address ID/FEI Business Operations Health and Natural Beauty USA Corp 079129688 MANUFACTURE(63404-1942)