Label: TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE- hydrogen peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 53462-120-60 - Packager: Sage Products LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 19, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
- INDICATIONS & USAGE
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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Directions
- Before opening, turn package over, burst solution packet with thumbs.
- Peel lid to open.
- Clean teeth and oral cavity for approximately one minute.
- Instruct to expectorate.
- Repeat cleaning with other swab as needed.
- Discard after use.
- Use up to 4 times daily or as directed by a dentist or doctor.
- Children under 12 years of age: supervise use.
- Children under 3 years of age: consult a dentist or doctor.
- Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
- Ensure foam is intact after use. If not, remove any particles from oral cavity.
- Inactive ingredients*
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE
hydrogen peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-120 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-120-60 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 POUCH 7 mL Part 1 of 1 ANTISEPTIC ORAL RINSE
cetylpyridinium chloride mouthwashProduct Information Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .5 [iU] in 1 mL Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) PEPPERMINT (UNII: V95R5KMY2B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 PACKAGE 1 2 in 1 PACKET 1 7 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/21/1998 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/31/2013 Labeler - Sage Products LLC (054326178) Registrant - Sage Products LLC (054326178) Establishment Name Address ID/FEI Business Operations Sage Products LLC 054326178 MANUFACTURE(53462-120)
