NEWYORK-PRESBYTERIAN AMENITY- sodium monofluorophospate 
ASP Global, LLc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NewYork-Presbyterian

Colgate® Anticavity Toothpaste

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 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

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

Questions or comments?

Call toll-free 1-800-468-6502

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

Colgate®
Anticavity Toothpaste

Cavity
Protection

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

PRINCIPAL DISPLAY PANEL - Amenity Kit

NewYork-Presbyterian

We are pleased to
present this welcome kit
for your comfort and
convenience during your
stay.

Thank you for choosing
New York-Presbyterian
for your healthcare!

Contents/Origins:
2.0 fl. oz. Shampoo/Conditioner
2.0 fl. oz. Body Wash
2.0 fl. oz. Body Lotion
2.2 fl. oz. Alcohol-free Mouthwash
0.15 oz. net wt. Lip Balm
0.85 oz. net wt. Soap Bar
Hair brush, Toothbrush, Ear plugs,
Sleep Mask and Kit Case:
Made in China
Toothpaste: Made in Thailand

Lawson #: 440016
Lot #:
Exp:

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

440016-I-A REV 3

Amenity Kit - Adult

Made in China:

Made in Thailand:

REF#: 440016

QTY: 20 KIT/CS

GROSS
WEIGHT: 10.5 kg

LOT #: XMMDDFC

EXP: YYYY-MM-DD

1
SINGLE
PATIENT
USE

NOT MADE
WITH
NATURAL
RUBBER
LATEX

DISTRIBUTED BY:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

NewYork-Presbyterian
The University Hospital of Columbia and Cornell

PRINCIPAL DISPLAY PANEL - Amenity Kit
NEWYORK-PRESBYTERIAN AMENITY 
sodium monofluorophospate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-100
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-100-001 in 1 BAG07/01/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 10 g
Part 21 TUBE 60 mL
Part 31 TUBE 60 mL
Part 41 TUBE 60 mL
Part 51 TUBE 4.25 g
Part 61 BOTTLE, PLASTIC 65 mL
Part 71 CELLO PACK 28 g
Part 1 of 7
COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Item Code (Source)NDC:42555-060
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)  
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42555-060-4510 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/04/2009
Part 2 of 7
GILCHRIST AND SOAMES   BODY BUTTER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRIsopropyl Palmitate (UNII: 8CRQ2TH63M)  
INGRCetostearyl Alcohol (UNII: 2DMT128M1S)  
INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
INGRIsopropyl Myristate (UNII: 0RE8K4LNJS)  
INGRBenzyl Alcohol (UNII: LKG8494WBH)  
INGRPeg-100 Stearate (UNII: YD01N1999R)  
INGRCarbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
INGRDehydroacetic Acid (UNII: 2KAG279R6R)  
INGRSodium Hydroxide (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC07/01/2013
Part 3 of 7
GILCHRIST AND SOAMES   HAIR 2 IN 1
shampoos (non-coloring) shampoo
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRSodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
INGRSodium Chloride (UNII: 451W47IQ8X)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRCocamidopropyl Betaine (UNII: 5OCF3O11KX)  
INGRCoco Monoethanolamide (UNII: C80684146D)  
INGRPolyquaternium-7 (70/30 Acrylamide/Dadmac; 2600000 MW) (UNII: U1G23TFV1K)  
INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
INGRMagnesium Nitrate (UNII: 77CBG3UN78)  
INGRMethylchloroisothiazolinone (UNII: DEL7T5QRPN)  
INGRMagnesium Chloride (UNII: 02F3473H9O)  
INGRMethylparaben (UNII: A2I8C7HI9T)  
INGRPropylparaben (UNII: Z8IX2SC1OH)  
INGRMethylisothiazolinone (UNII: 229D0E1QFA)  
INGRFD&C Yellow No. 5 (UNII: I753WB2F1M)  
INGRFD&C Red No. 4 (UNII: X3W0AM1JLX)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC07/01/2013
Part 4 of 7
GILCHRIST AND SOAMES   BODY REFRESHER--BODY WASH
skin fresheners liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRSodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
INGRSodium Chloride (UNII: 451W47IQ8X)  
INGRCocamidopropyl Betaine (UNII: 5OCF3O11KX)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRPolyquaternium-7 (70/30 Acrylamide/Dadmac; 2600000 MW) (UNII: U1G23TFV1K)  
INGRCoco Monoethanolamide (UNII: C80684146D)  
INGRMagnesium Nitrate (UNII: 77CBG3UN78)  
INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
INGRMethylchloroisothiazolinone (UNII: DEL7T5QRPN)  
INGRMagnesium Chloride (UNII: 02F3473H9O)  
INGRMethylisothiazolinone (UNII: 229D0E1QFA)  
INGRFD&C Yellow NO. 5 (UNII: I753WB2F1M)  
INGRFD&C Red NO. 4 (UNII: X3W0AM1JLX)  
INGRFD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC07/01/2013
Part 5 of 7
GILCHRIST AND SOAMES   MOISTURIZING LIP BALM
lipstick lipstick
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCeresin (UNII: Q1LS2UJO3A)  
INGREthylhexyl Palmitate (UNII: 2865993309)  
INGRMineral Oil (UNII: T5L8T28FGP)  
INGRPetrolatum (UNII: 4T6H12BN9U)  
INGRHydrogenated Polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)  
INGRPolybutene (1400 MW) (UNII: 1NA5AO9GH7)  
INGRMicrocrystalline Wax (UNII: XOF597Q3KY)  
INGRCandelilla Wax (UNII: WL0328HX19)  
INGRSilicon Dioxide (UNII: ETJ7Z6XBU4)  
INGRPentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)  
INGRPropylparaben (UNII: Z8IX2SC1OH)  
INGRFD&C Yellow No. 5 (UNII: I753WB2F1M)  
INGRACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14.25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC07/01/2013
Part 6 of 7
ASP GLOBAL, LLC  ALCOHOL-FREE
mouthwashes and breath fresheners (liquids and sprays) mouthwash
Product Information
Route of AdministrationORAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
INGRSodium Benzoate (UNII: OJ245FE5EU)  
INGRMenthol, Unspecified Form (UNII: L7T10EIP3A)  
INGRSaccharin Sodium (UNII: SB8ZUX40TY)  
INGRCetylpyridinium Chloride (UNII: D9OM4SK49P)  
INGRFD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
165 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC07/01/2013
Part 7 of 7
ASP GLOBAL, LLC  CLEANSING GLYCERENE BAR
bath soaps and detergents soap
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSodium Palmitate (UNII: JQ43KP6296)  
INGRSodium Cocoate (UNII: R1TQH25F4I)  
INGRWater (UNII: 059QF0KO0R)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRSodium Chloride (UNII: 451W47IQ8X)  
INGRPalmitic Acid (UNII: 2V16EO95H1)  
INGREdetic Acid (UNII: 9G34HU7RV0)  
INGRTitanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
128 g in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC07/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/01/2013
Labeler - ASP Global, LLc (080361159)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-100)
Establishment
NameAddressID/FEIBusiness Operations
Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-100) , LABEL(59448-100)

Revised: 12/2022
Document Id: 8fcf0bfa-03c7-4f8f-a247-28d3463ded03
Set id: 4b307471-445d-4c51-a499-d074a8172f20
Version: 9
Effective Time: 20221214
 
ASP Global, LLc