Label: UNITED AIRLINES TRANSCON KIT- sodium monofluorophosphate, alcohol kit
- NDC Code(s): 42555-060-94, 69491-035-01, 69491-038-01
- Packager: Buzz Export Services Pty Ltd (Buzz Products)
- 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 January 10, 2023
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- Package Labeling:69491-038-01
- Package Labeling:42555-060-94
- Package Labeling:69491-035-01
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INGREDIENTS AND APPEARANCE
UNITED AIRLINES TRANSCON KIT
sodium monofluorophosphate, alcohol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69491-038 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69491-038-01 1 in 1 KIT 02/15/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 5 g Part 2 1 PATCH 5 mL Part 1 of 2 COLGATE ANTICAVITY
sodium monofluorophosphate paste, dentifriceProduct Information Item Code (Source) NDC:42555-060 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYL SALICYLATE (UNII: LAV5U5022Y) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42555-060-94 5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/15/2022 Part 2 of 2 SANITIZER WIPE IN SACHET
alcohol clothProduct Information Item Code (Source) NDC:69491-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69491-035-01 1 in 1 PACKAGE 1 5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part355 02/15/2022 Labeler - Buzz Export Services Pty Ltd (Buzz Products) (747317902)