FDA.reportPublic FDA data

Univ of Vermont Medical Center Amenity

Manufacturer
ASP Global, LLc | Shengzhou Kingbird Travel Products Co., Ltd. | Colgate-Palmolive (Thailand) LTD | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:34

Label at a glance#

ProductUniv of Vermont Medical Center Amenity
Active ingredientBenzalkonium Chloride, Sodium Monofluorophosphate
Label structure20 sections

Indications and uses

To help reduce bacteria on hands.

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Colgate® Anticavity Toothpaste

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Manufactured by:
COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.

SPL UNCLASSIFIED SECTION

Instant Hand Antiseptic

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.095%

Propose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To help reduce bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Rub dime sized amount between hands until dry.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Methylisothiazolinone, Propylene Glycol, Polyquaternium-37, Triethanolamine, Water

SPL UNCLASSIFIED SECTION

Distributed by:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

7
OTHER

PRINCIPAL DISPLAY PANEL - 10 g Tube Label
PRINCIPAL DISPLAY PANEL - 10 g Tube Label

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASP
MEDICAL

Instant Hand Antiseptic
Alcohol & Fragrance Free

1.9 FL OZ / 53 mL

Distributed by:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

Rev 02

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

PRINCIPAL DISPLAY PANEL - Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Thailand

Lot #: XMMDDFC
Exp: YYYY-MM-DD

Distributed by:
ASP Global, LLC
7800 Third Flag Parkway, Austell, GA 30168

REV 01

THE
University of Vermont
MEDICAL CENTER

Item #: 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 China

Components 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

PRINCIPAL DISPLAY PANEL - Kit Label
PRINCIPAL DISPLAY PANEL - Kit Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2048259benzalkonium chloride 0.095 % Topical GelPSN5
545626sodium monofluorophosphate 0.76 % ToothpastePSN5
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
2048259benzalkonium chloride 0.095 % Topical GelSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-003-01Univ of Vermont Medical Center Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL0.095 mg in 100mL5
59448-500-00Univ of Vermont Medical Center Amenity1 in 1 BAGKIT15
59448-500-00Univ of Vermont Medical Center Amenity20 in 1 BOXKIT205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-060UNIV OF VERMONT MEDICAL CENTER AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]5Current NDC, Legacy NDC20241222_7841cfa9-e94e-4c3d-b5fb-676924017845.zip
59448-003UNIV OF VERMONT MEDICAL CENTER AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]5Current NDC, Legacy NDC20241222_7841cfa9-e94e-4c3d-b5fb-676924017845.zip
59448-500UNIV OF VERMONT MEDICAL CENTER AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]5Current NDC, Legacy NDC, 3 package rows20241222_7841cfa9-e94e-4c3d-b5fb-676924017845.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59448-50059448-500-00
59448-00359448-003-01
42555-06042555-060-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
Polyquaternium-37 (25000 MPA.S)31L31U8285IACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Methylisothiazolinone229D0E1QFAIACT
Trolamine9O3K93S3TKIACT
Sodium MonofluorophosphateC810JCZ56QACTIM
Dibasic Calcium Phosphate DihydrateO7TSZ97GEPIACT
Water059QF0KO0RIACT
Sorbitol506T60A25RIACT
Sodium Lauryl Sulfate368GB5141JIACT
Sodium PyrophosphateO352864B8ZIACT
Saccharin SodiumSB8ZUX40TYIACT
ETHYLHEXYL PALMITATE2865993309INGR
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINGR
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KINGR
YELLOW WAX2ZA36H0S2VINGR
HIGH DENSITY POLYETHYLENEUG00KM4WR7INGR
SHEANUT OILO88E196QRFINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
PHENOXYETHANOLHIE492ZZ3TINGR
YELLOWCOLR

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
ndc (package): 59448-500-00
ndc (package): 42555-060-45
ndc (package): 59448-003-01
ndc (product): 59448-500
ndc11 (package): 59448000301
ndc11 (package): 59448050000
ndc11 (package): 42555006045
spl id: 0c95a7bb-2b60-4850-b697-9c568cd9b5e6
spl set id: 7841cfa9-e94e-4c3d-b5fb-676924017845
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
ndc (package): 42555-060-45
ndc (product): 42555-060
ndc11 (package): 42555006045
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global47276148-08e5-400e-94ac-d2d9db423b512024-12-06WarningsExact identifier
ndc (package): 59448-003-01
ndc (product): 59448-003
ndc11 (package): 59448000301
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.