Label: ORAL-B- sodium fluoride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0041-1421-16 - Packager: Oral-B Laboratories
- 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 April 2, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste.
- Vigorously swish 10ml (as indicated inside cap) of rinse between your teeth for 1 minute then spit out. Do not swallow.
- Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in good rinsing habits to minimize swallowing.
- Supervise children as necessary until capable of using without supervision.
- Consult a dentist or physician for use by children under 6 years of age.
- Other information
- Inactive ingredients
- Question or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500ml Label
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INGREDIENTS AND APPEARANCE
ORAL-B ANTICAVITY
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0041-1421 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride 500 ug in 1 mL Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0041-1421-16 500 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part355 10/15/2005 Labeler - Oral-B Laboratories (183102243)