MEMORIAL SLOAN KETTERING CANCER CENTER AMENITY KIT- sodium monofluorophosphate kit

Memorial Sloan Kettering Cancer Center Amenity Kit by

Drug Labeling and Warnings

Memorial Sloan Kettering Cancer Center Amenity Kit by is a Otc medication manufactured, distributed, or labeled by ASP Global, LLc, Shengzhou Kingbird Travel Products Co., Ltd., Colgate-Palmolive (Thailand) LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

helps protect against cavities

Warnings

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

• 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

dicalcium phosphate dihydrate, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

Questions or comments?

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

7
OTHER

PRINCIPAL DISPLAY PANEL - Kit Label

Memorial Sloan Kettering
Cancer Center

Contents/Origins:

0.15 oz. net wt. Lip Balm
Toothbrush, Ear Plug, Sleep Mask, Facial Tissue,
Denture Cup, Headphone, Notepad, Patient Name Card,
Welcome Card, Sudoku/Crossword Book, My Care
Booklet, Ballpen, and Kit Case: Made in China
Toothpaste: Made in Thailand

Lot #:
Exp:

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331
REV 01

Memorial Sloan Kettering
Cancer Center

Item #: MSKAKT01
Description: Amenity Kit

PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 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:

• Lip Balm
• Toothbrush
• Ear Plug
• Sleep Mask
• Facial Tissue
• Denture Cup
• Headphone
• Notepad
• Patient Name Card
• Welcome Card
• Sudoku/Crossword Book
• My Care Booklet
• Ballpen
• Kit Case

Component Made in Thailand:

• Toothpaste

Memorial Sloan Kettering
Cancer Center

Name Card

Patient Name:

INGREDIENTS AND APPEARANCE

MEMORIAL SLOAN KETTERING CANCER CENTER AMENITY KIT 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-300

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-300-00	1 in 1 BAG	04/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 g
Part 2	1 TUBE	4.25 g

Part 1 of 2

COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product 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)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
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 2 of 2

MEMORIAL SLOAN KETTERING CANCER CENTER   LIP BALM
lipstick

Product 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	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

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		04/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	04/01/2017

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-300) , LABEL(59448-300) , REPACK(59448-300)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) LTD		672044552	MANUFACTURE(59448-300)