NDC | 0273-8008-01, 0273-8008-02 |
Set ID | 4ca4be4a-6590-465f-be63-ee50bd421748 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Young Dental Manufacturing I, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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)