Label: SPRINJENE FRESH BOOST- sodium fluoride gel, dentifrice
- NDC Code(s): 63404-0910-1, 63404-0910-2
- Packager: Health and Natural Beauty USA Corp
- 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 February 2, 2023
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- Official Label (Printer Friendly)
- 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 under 2 to 6 years instruct in good brushing and rinsing habbits (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 - 130 g Tube Carton
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INGREDIENTS AND APPEARANCE
SPRINJENE FRESH BOOST
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63404-0910 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Hydrated Silica (UNII: Y6O7T4G8P9) Glycerin (UNII: PDC6A3C0OX) Sorbitol (UNII: 506T60A25R) Sodium Lauryl Sulfate (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) Zinc Citrate (UNII: K72I3DEX9B) Guizotia Abyssinica Seed Oil (UNII: QX0GL46299) Sodium Pyrophosphate (UNII: O352864B8Z) Xanthan Gum (UNII: TTV12P4NEE) Saccharin Sodium (UNII: SB8ZUX40TY) Mica (UNII: V8A1AW0880) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Yellow No. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape Size Flavor MINT (Minty) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63404-0910-1 1 in 1 CARTON 10/10/2014 1 130 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:63404-0910-2 1 in 1 CARTON 10/10/2014 2 42 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 10/10/2014 Labeler - Health and Natural Beauty USA Corp (079129688) Establishment Name Address ID/FEI Business Operations Health and Natural Beauty USA Corp 079129688 MANUFACTURE(63404-0910)
