NDC | 0273-8016-03 |
Set ID | a7c7c0b7-4f74-434f-9628-6af58dd60cff |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Young Dental Manufacturing Co 1, 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 PACKETS VERY BERRY
sodium fluoride powderProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8016 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 BERRY (very berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0273-8016-03 50 in 1 PACKAGE 09/21/2017 1 3 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/21/2017 Labeler - Young Dental Manufacturing Co 1, LLC. (006309355) Registrant - Young Dental Manufacturing Co 1, LLC. (006309355) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(0273-8016)