GRACIE SQUARE HOSPITAL AMENITY- sodium monofluorophosphate kit

Gracie Square Hospital Amenity by

Drug Labeling and Warnings

Gracie Square Hospital Amenity 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

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, 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

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

PRINCIPAL DISPLAY PANEL - Kit Label

GRACIE
SQUARE
HOSPITAL

Item #: GSHAMEN01

Description: Amenity Kit

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
• Hair Brush
• Toothbrush
• Ear Plugs
• Lip Balm
• Kit Case

Component Made in Thailand:

• Toothpaste

GRACIE
SQUARE
HOSPITAL

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

Thank you for choosing
Gracie Square Hospital
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
Hair Brush, Toothbrush, Ear Plugs,
and Kit Case: Made in China
Toothpaste: Made in Thailand

Lot #:
Exp:

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

GSHAMEN01 Rev 2

GRACIE
SQUARE
HOSPITAL

INGREDIENTS AND APPEARANCE

GRACIE SQUARE HOSPITAL AMENITY 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-101

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-101-00	1 in 1 BAG	01/18/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 g
Part 2	1 TUBE	59 mL
Part 3	1 TUBE	59 mL
Part 4	1 TUBE	59 mL
Part 5	1 TUBE	4.25 g
Part 6	1 BOTTLE, PLASTIC	65 mL

Part 1 of 6

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 6

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

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	C48325

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 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 6

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

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	C48330

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 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 6

GILCHRIST AND SOAMES   BODY REFRESHER--BODY WASH
skin fresheners

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	C48329

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 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 6

GILCHRIST AND SOAMES   MOISTURIZING LIP BALM
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	C48330

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 6

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

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	C48333
flavor	MINT	C73404

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/18/2016

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-101) , LABEL(59448-101) , REPACK(59448-101)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) LTD		672044552	MANUFACTURE(59448-101)