Label: NAFRINSE PACKETSKIT BUBBLE GUM- sodium fluoride powder
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Contains inactivated NDC Code(s)
NDC Code(s): 0273-8008-01, 0273-8008-02 - Packager: Young Dental Manufacturing I, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 13, 2018
If you are a consumer or patient please visit this version.
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- Inactives
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Warning:
This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only.
DO NOT SWALLOW
MISSUSE If child swallows dispensed amount of mouth rinse in a cup:
1. Do not panic -this amount should not hurt the child
2. In rare cases the child may feel slightly nauseous.
The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222
- Directions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAFRINSE PACKETSKIT BUBBLE GUM
sodium fluoride powderProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8008 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 g in 1 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) Potassium Sorbate (UNII: 1VPU26JZZ4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM (bubble gum) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0273-8008-02 20 in 1 KIT 09/25/2017 1 NDC:0273-8008-01 3 g in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/25/2017 Labeler - Young Dental Manufacturing I, LLC (006309355) Registrant - Young Dental Manufacturing I, LLC (006309355) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc 002290302 manufacture(0273-8008)
