NEWYORK-PRESBYTERIAN AMENITY- sodium monofluorophospate kit

NewYork-Presbyterian Amenity by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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, 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 - 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
3450 Atlanta Industrial Parkway
Atlanta, GA 30331

440016-I-A REV 2

Amenity Kit - Adult

Made in China:

• Shampoo/Conditioner
• Body Wash
• Body Lotion
• Alcohol-Free Mouthwash
• Hair Brush
• Toothbrush
• Ear Plugs
• Facial Soap
• Lip Moisturizer
• Sleep Mask
• Kit Case

Made in Thailand:

• Toothpaste

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
3450 Atlanta Industrial Parkway
Atlanta, GA 30331

NewYork-Presbyterian
The University Hospital of Columbia and Cornell

INGREDIENTS AND APPEARANCE

NEWYORK-PRESBYTERIAN AMENITY 
sodium monofluorophospate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-100

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-100-00	1 in 1 BAG	07/01/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 g
Part 2	1 TUBE	60 mL
Part 3	1 TUBE	60 mL
Part 4	1 TUBE	60 mL
Part 5	1 TUBE	4.25 g
Part 6	1 BOTTLE, PLASTIC	65 mL
Part 7	1 CELLO PACK	28 g

Part 1 of 7

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)
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 7

GILCHRIST AND SOAMES   BODY BUTTER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Isopropyl Palmitate (UNII: 8CRQ2TH63M)
INGR	Cetostearyl Alcohol (UNII: 2DMT128M1S)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	Cyclomethicone 5 (UNII: 0THT5PCI0R)
INGR	Isopropyl Myristate (UNII: 0RE8K4LNJS)
INGR	Benzyl Alcohol (UNII: LKG8494WBH)
INGR	Peg-100 Stearate (UNII: YD01N1999R)
INGR	Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
INGR	Dehydroacetic Acid (UNII: 2KAG279R6R)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL 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		07/01/2013

Part 3 of 7

GILCHRIST AND SOAMES   HAIR 2 IN 1
shampoos (non-coloring) shampoo

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Coco Monoethanolamide (UNII: C80684146D)
INGR	Polyquaternium-7 (70/30 Acrylamide/Dadmac; 2600000 MW) (UNII: U1G23TFV1K)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Magnesium Nitrate (UNII: 77CBG3UN78)
INGR	Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
INGR	Magnesium Chloride (UNII: 02F3473H9O)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Propylparaben (UNII: Z8IX2SC1OH)
INGR	Methylisothiazolinone (UNII: 229D0E1QFA)
INGR	FD&C Yellow No. 5 (UNII: I753WB2F1M)
INGR	FD&C Red No. 4 (UNII: X3W0AM1JLX)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL 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		07/01/2013

Part 4 of 7

GILCHRIST AND SOAMES   BODY REFRESHER--BODY WASH
skin fresheners liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Polyquaternium-7 (70/30 Acrylamide/Dadmac; 2600000 MW) (UNII: U1G23TFV1K)
INGR	Coco Monoethanolamide (UNII: C80684146D)
INGR	Magnesium Nitrate (UNII: 77CBG3UN78)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
INGR	Magnesium Chloride (UNII: 02F3473H9O)
INGR	Methylisothiazolinone (UNII: 229D0E1QFA)
INGR	FD&C Yellow NO. 5 (UNII: I753WB2F1M)
INGR	FD&C Red NO. 4 (UNII: X3W0AM1JLX)
INGR	FD&C Blue No. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL 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		07/01/2013

Part 5 of 7

GILCHRIST AND SOAMES   MOISTURIZING LIP BALM
lipstick lipstick

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Ceresin (UNII: Q1LS2UJO3A)
INGR	Ethylhexyl Palmitate (UNII: 2865993309)
INGR	Mineral Oil (UNII: T5L8T28FGP)
INGR	Petrolatum (UNII: 4T6H12BN9U)
INGR	Hydrogenated Polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)
INGR	Polybutene (1400 MW) (UNII: 1NA5AO9GH7)
INGR	Microcrystalline Wax (UNII: XOF597Q3KY)
INGR	Candelilla Wax (UNII: WL0328HX19)
INGR	Silicon Dioxide (UNII: ETJ7Z6XBU4)
INGR	Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
INGR	Propylparaben (UNII: Z8IX2SC1OH)
INGR	FD&C Yellow No. 5 (UNII: I753WB2F1M)
INGR	ACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F)

Product Characteristics
Color	YELLOW	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		07/01/2013

Part 6 of 7

ASP GLOBAL, LLC  ALCOHOL-FREE
mouthwashes and breath fresheners (liquids and sprays) mouthwash

Product Information
Route of Administration	ORAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Menthol, Unspecified Form (UNII: L7T10EIP3A)
INGR	Saccharin Sodium (UNII: SB8ZUX40TY)
INGR	Cetylpyridinium Chloride (UNII: D9OM4SK49P)
INGR	FD&C Blue No. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		65 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		07/01/2013

Part 7 of 7

ASP GLOBAL, LLC  CLEANSING GLYCERENE BAR
bath soaps and detergents soap

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Sodium Palmitate (UNII: JQ43KP6296)
INGR	Sodium Cocoate (UNII: R1TQH25F4I)
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Palmitic Acid (UNII: 2V16EO95H1)
INGR	Edetic Acid (UNII: 9G34HU7RV0)
INGR	Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 g in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/01/2013

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) LTD		672044552	MANUFACTURE(59448-100)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-100) , LABEL(59448-100) , REPACK(59448-100)