Label: UNIV OF VERMONT MEDICAL CENTER AMENITY- benzalkonium chloride and sodium monofluorophosphate kit
- NDC Code(s): 42555-060-45, 59448-003-01, 59448-500-00
- Packager: ASP Global, LLc
- 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 December 14, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Propose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 g Tube Label
- PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
-
PRINCIPAL DISPLAY PANEL - Kit Label
We strive to provide a quiet environment for you
to rest in during your stay. This Welcome Packet
contains some items that are helpful in reducing
hospital noise.The best healing happens in a quiet environment.
You can help by:
- Using a headset when watching TV
- Keeping cell phones on vibrate
- Speaking softly
- Asking family and friends to visit two at a time
We are honored to care for you.
Contents/Origins:
1.9 fl. oz. Alcohol and Fragrance Free Hand Sanitizer,
0.15 oz. net wt. Lip Balm,
Toothbrush, Sleep Mask, Ear Plugs, Notebook, Pen and
Kit Case: Made in China
Toothpaste: Made in ThailandLot #: XMMDDFC
Exp: YYYY-MM-DDDistributed by:
ASP Global, LLC
7800 Third Flag Parkway, Austell, GA 30168REV 01
THE
University of Vermont
MEDICAL CENTERItem #: UNVMC01
Description: AMENITY KIT, UVMC,
GREEN, ZIPPERED
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 KIT/CS
Carton #: XXX of XXXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: 57.0 x 17.0 x 27.0 CM
Assembled in ChinaComponents Made in China:
- Alcohol and Fragrance Free Hand Sanitizer
- Lip Balm
- Toothbrush
- Sleep Mask
- Ear Plugs
- Notebook
- Pen
- Kit Case
Component Made in Thailand:
- Toothpaste
THE
University of Vermont
MEDICAL CENTER -
INGREDIENTS AND APPEARANCE
UNIV OF VERMONT MEDICAL CENTER AMENITY
benzalkonium chloride and sodium monofluorophosphate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59448-500 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59448-500-00 20 in 1 BOX 12/05/2018 1 1 in 1 BAG Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 53 mL Part 2 1 TUBE 10 g Part 3 1 TUBE 4.25 g Part 1 of 3 INSTANT HAND ANTISEPTIC
benzalkonium chloride gelProduct Information Item Code (Source) NDC:59448-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 0.095 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Polyquaternium-37 (25000 MPA.S) (UNII: 31L31U8285) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Methylisothiazolinone (UNII: 229D0E1QFA) Trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59448-003-01 53 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/05/2018 Part 2 of 3 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) 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:42555-060-45 10 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 06/04/2009 Part 3 of 3 ASP GLOBAL LIP BALM
lipstickProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR SHEANUT OIL (UNII: O88E196QRF) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics color YELLOW C48330 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.25 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 Cosmetic 12/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/05/2018 Labeler - ASP Global, LLc (080361159) Establishment Name Address ID/FEI Business Operations Shengzhou Kingbird Travel Products Co., Ltd. 560219293 PACK(59448-500) , LABEL(59448-500) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive (Thailand) LTD 672044552 MANUFACTURE(59448-500) Establishment Name Address ID/FEI Business Operations Nantong Health & Beyond Hygienic Products Inc. 421280161 MANUFACTURE(59448-500)