FDA.reportPublic FDA data

Sarasota Memorial 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
4
Source
full-release
Hydrated at
2026-06-01 00:48:06

Label at a glance#

ProductSarasota Memorial Amenity
Active ingredientALCOHOL, SODIUM MONOFLUOROPHOSPHATE
Label structure21 sections

Indications and uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

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

Storage and handling

Do not store above 110°F. May discolor some fabrics.

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

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help.

Directions

DOSAGE & ADMINISTRATION SECTION

Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

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

Other Information

STORAGE AND HANDLING SECTION

Do not store above 110°F. May discolor some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASP
MEDICAL

Instant Hand Antiseptic
62% w/w Ethyl Alcohol

1.9 FL OZ / 53 mL

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

Rev 01

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

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 - Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SARASOTA
MEMORIAL
HEALTH CARE SYSTEM

Contents/Origins:

1.9 fl. oz. Hand Sanitizer
Toothbrush, Sleep Mask, Ear Plugs, Facial Tissue, Patient
Hand Hygiene Education Card, Paper Bag 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, USA

REV 02

SARASOTA
MEMORIAL
HEALTH CARE SYSTEM

Item #: SARASOTA01
Description: AMENITY KIT, SARASOTA
MEM WELCOME
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 KIT/CS
Carton #: XXX of XXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: XX x XX x XX CM
Assembled in China

Components Made in China:

  • Hand Sanitizer
  • Toothbrush
  • Sleep Mask
  • Ear Plugs
  • Facial Tissue
  • Paper Bag
  • Kit Case

Component Made in Thailand:

  • Toothpaste

SARASOTA
MEMORIAL
HEALTH CARE SYSTEM

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN4
545626sodium monofluorophosphate 0.76 % ToothpastePSN4
581660ethanol 0.62 ML/ML Topical GelSCD4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4
581660ethanol 62 % Topical GelSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-004-01Sarasota Memorial Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-600-00Sarasota Memorial Amenity30 in 1 BOXKIT304
59448-600-00Sarasota Memorial Amenity1 in 1 BAGKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-060SARASOTA MEMORIAL AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC20241222_f5dda019-fcfd-4e99-89cc-e79e76b402e7.zip
59448-004SARASOTA MEMORIAL AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC20241222_f5dda019-fcfd-4e99-89cc-e79e76b402e7.zip
59448-600SARASOTA MEMORIAL AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC, 3 package rows20241222_f5dda019-fcfd-4e99-89cc-e79e76b402e7.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59448-60059448-600-00
59448-00459448-004-01
42555-06042555-060-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
Aloe Vera LeafZY81Z83H0XIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
Trolamine9O3K93S3TKIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
Water059QF0KO0RIACT
Sorbitol506T60A25RIACT
Sodium Lauryl Sulfate368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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): 42555-060-45
ndc11 (package): 42555006045
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): 59448-004-01
ndc (package): 42555-060-45
ndc (package): 59448-600-00
ndc (product): 59448-600
ndc11 (package): 59448060000
ndc11 (package): 42555006045
ndc11 (package): 59448000401
spl id: db5d3143-b67b-4dd3-b751-012f3ba86db9
spl set id: f5dda019-fcfd-4e99-89cc-e79e76b402e7
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 AntisepticALCOHOLASP Globalb84075db-be0c-4265-b262-825bc6ade9d82024-12-06WarningsExact identifier
ndc (package): 59448-004-01
ndc (product): 59448-004
ndc11 (package): 59448000401
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
ndc (package): 59448-004-01
ndc (package): 42555-060-45
ndc11 (package): 42555006045
ndc11 (package): 59448000401

Reported adverse events (FAERS/openFDA)#

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