FDA.reportPublic FDA data

Wellstar 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 00:47:53

Label at a glance#

ProductWellstar 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

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.

Storage and handling

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

Label contents#

Full prescribing information#

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

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

Wellstar

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 00

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

Wellstar

Item #: WSHKIT02
Description: AMENITY KIT, WELLSTAR
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: XXX of XXXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: 65.0 x 20.0 x 33.0 CM

Assembled in China

Components Made in China:

  • Hand Sanitizer
  • Alcohol-Free Mouthwash
  • Lip Balm
  • Toothbrush
  • Hairbrush
  • Body Lotion
  • Body Wash
  • Shampoo/Conditioner
  • Deodorant Stick
  • Facial Tissue
  • Nail File
  • Pen
  • Notepad
  • Kit Case

Component Made in Thailand:

  • Toothpaste

WSHKIT02-MC-00

Wellstar

Contents/Origins:

2.0 fl. oz. Shampoo/Conditioner
2.0 fl. oz. Body Wash
2.0 fl. oz. Body Lotion
2.0 fl. oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
0.5 oz. net wt. Deodorant Stick
1.9 fl. oz. Hand Sanitizer

Toothbrush, Hairbrush, Facial Tissue, Nail File, Pen, Notepad,
and Kit Case: Made in China
Toothpaste: Made in Thailand

Lot #:
Exp:

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

REV 00

Wellstar

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 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
59448-008-01Wellstar Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-800-00Wellstar Amenity20 in 1 BOXKIT204
59448-800-00Wellstar Amenity1 in 1 BAGKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-060WELLSTAR AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC20241222_ced9dd96-7922-43d7-906f-32afaad733ec.zip
59448-008WELLSTAR AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC20241222_ced9dd96-7922-43d7-906f-32afaad733ec.zip
59448-800WELLSTAR AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC, 3 package rows20241222_ced9dd96-7922-43d7-906f-32afaad733ec.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
59448-80059448-800-00
59448-00859448-008-01
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
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
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): 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
ndc (package): 59448-800-00
ndc (package): 59448-008-01
ndc (product): 59448-800
ndc11 (package): 42555006045
ndc11 (package): 59448080000
ndc11 (package): 59448000801
spl id: 961c53ef-0590-4aa8-8cef-667615bd0c4b
spl set id: ced9dd96-7922-43d7-906f-32afaad733ec
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 AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
ndc (package): 59448-008-01
ndc (product): 59448-008
ndc11 (package): 59448000801
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.