FDA.reportPublic FDA data

Englewood 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
8
Source
full-release
Hydrated at
2026-06-01 00:47:34

Label at a glance#

ProductEnglewood Amenity
Active ingredientBenzalkonium Chloride, SODIUM MONOFLUOROPHOSPHATE
Label structure20 sections

Indications and uses

To help reduce bacteria on hands.

Dosage and administration

Rub dime sized amount between hands until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Instant Hand Antiseptic

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.095%

Purpose

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

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.

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENGLEWOOD
HEALTH

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 04

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

PT505037

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

ENGLEWOOD
HEALTH

Contents/Origins:

2.0 fl.oz. G&S Shampoo/Conditioner
2.0 fl.oz. G&S Body Wash
2.0 fl.oz. G&S Body Lotion
2.0 fl.oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
0.1 oz. G&S Deodorant
1.9 fl.oz. Alcohol-Free Hand Sanitizer
Toothbrush Case, Toothbrush, Hairbrush, Nail File, Eye Mask,
Ear Plugs, Ear Phones, 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

ENGLEWOOD
HEALTH

Item #: ENGLWD1
Description: Amenity Kit, Englewood

PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: X of XX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: NN x NN x NN CM

Assembled in China

Components Made in China:

  • Shampoo/Conditioner
  • Body Wash
  • Body Lotion
  • Alcohol-Free Mouthwash
  • Lip Balm
  • Deodorant
  • Alcohol-Free Hand Sanitizer
  • Toothbrush Case
  • Toothbrush
  • Hairbrush
  • Nail File,
  • Eye Mask,
  • Ear Plugs
  • Ear Phones
  • Kit Case

Component Made in Thailand:

  • Toothpaste

ENGLEWOOD
HEALTH

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 GelPSN8
545626sodium monofluorophosphate 0.76 % ToothpastePSN8
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD8
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD8
2048259benzalkonium chloride 0.095 % Topical GelSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-002-01Englewood Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL0.095 mg in 100mL8
59448-400-00Englewood Amenity20 in 1 BOXKIT208
59448-400-00Englewood Amenity1 in 1 BAGKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-060ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.zip
59448-002ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.zip
59448-400ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC, 3 package rows20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.zip

Products#

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

DailyMed product names page 1 of 2 · 76 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59448-40059448-400-00
59448-00259448-002-01
42555-06042555-060-45

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 95 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
Water059QF0KO0RINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CYCLOMETHICONE 50THT5PCI0RINGR
ISOPROPYL MYRISTATE0RE8K4LNJSINGR
BENZYL ALCOHOLLKG8494WBHINGR
PEG-100 STEARATEYD01N1999RINGR
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EINGR
DEHYDROACETIC ACID2KAG279R6RINGR
SODIUM HYDROXIDE55X04QC32IINGR
WHITECOLR
Water059QF0KO0RINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
SODIUM CHLORIDE451W47IQ8XINGR
GLYCERINPDC6A3C0OXINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
COCO MONOETHANOLAMIDEC80684146DINGR
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW)U1G23TFV1KINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
MAGNESIUM NITRATE77CBG3UN78INGR
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNINGR
MAGNESIUM CHLORIDE02F3473H9OINGR
METHYLPARABENA2I8C7HI9TINGR
PROPYLPARABENZ8IX2SC1OHINGR
METHYLISOTHIAZOLINONE229D0E1QFAINGR

Source Document#

Source XML

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): 59448-002-01
ndc (package): 42555-060-45
ndc11 (package): 59448000201
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): 42555-060-45
ndc11 (package): 42555006045
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
ndc (package): 59448-002-01
ndc (package): 42555-060-45
ndc (package): 59448-400-00
ndc (product): 59448-400
ndc11 (package): 59448000201
ndc11 (package): 59448040000
ndc11 (package): 42555006045
spl id: e82aa749-3427-4411-95f4-75d74665a58d
spl set id: 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2
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 Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
ndc (package): 59448-002-01
ndc (product): 59448-002
ndc11 (package): 59448000201
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.