EMORY JOHNS CREEK AMENITY- alcohol and sodium monofluorophospate kit

Emory Johns Creek Amenity by

Drug Labeling and Warnings

Emory Johns Creek Amenity by is a Otc medication manufactured, distributed, or labeled by ASP Global, LLc, Shengzhou Kingbird Travel Products Co., Ltd., Colgate-Palmolive (Thailand) LTD, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Instant Hand Antiseptic

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help.

Directions

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

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

Inactive Ingredients

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

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 - 53 mL Bottle Label

ASP
MEDICAL

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 01

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

7
OTHER

PRINCIPAL DISPLAY PANEL - Kit Label

EMORY
JOHNS CREEK
HOSPITAL

Item #: EJCKIT01
Description: AMENITY KIT,
EMORY JOHNS CREEK
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 KIT/CS
Carton #: XXX of XXXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: 54.0 x 19.0 x 27.0 CM

Assembled in China

Components Made in China:

• Alcohol and Fragrance Free Hand Sanitizer
• Lip Balm Ball
• Toothbrush
• Sleep Mask
• Ear Plugs
• Body Lotion
• Deodorant Stick
• Kit Case

Component Made in Thailand:

• Toothpaste

EMORY
JOHNS CREEK
HOSPITAL

On behalf of the entire Emory Johns Creek Hospital family,
we thank you for trusting us with your care. Our goal is to
provide all our patients with a nurturing and healing
environment, and we hope this kit adds to your comfort
during your stay. Please let us know what we can do to
make your stay more comfortable.

Contents/Origins:

1.9 fl. oz. Hand Sanitizer,
0.25 oz. net wt. Lip Balm Ball,
2 fl. oz. Body Lotion,
0.5 oz. net wt. Deodorant Stick,
Toothbrush, Sleep Mask, Ear Plugs, and Kit Case:
Made in China
Toothpaste: Made in Thailand

Lot #: XMMDDFC
Exp: YYYY-MM-DD

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

REV 02

EMORY
JOHNS CREEK
HOSPITAL

INGREDIENTS AND APPEARANCE

EMORY JOHNS CREEK AMENITY 
alcohol and sodium monofluorophospate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-700

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-700-00	30 in 1 BOX	07/27/2020
1		1 in 1 BAG

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	53 mL
Part 2	1 TUBE	10 g
Part 3	1 TUBE	59 mL
Part 4	1 TUBE	4.25 g
Part 5	1 BOTTLE, WITH APPLICATOR	14 g

Part 1 of 5

INSTANT HAND ANTISEPTIC 
alcohol gel

Product Information
Item Code (Source)	NDC: 59448-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-004-01	53 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
OTC MONOGRAPH NOT FINAL	part333E	10/15/2019

Part 2 of 5

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 3 of 5

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

Product Information

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		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 5

EMORY JOHNS CREEK   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	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		06/13/2018

Part 5 of 5

GILCHRIST AND SOAMES   DEODORANT
deodorants (underarm)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	WHITE WAX (UNII: 7G1J5DA97F)
INGR	Starch, Rice (UNII: 4DGK8B7I3S)
INGR	Lavender Oil (UNII: ZBP1YXW0H8)
INGR	Tannic Acid (UNII: 28F9E0DJY6)
INGR	Sodium Lactate (UNII: TU7HW0W0QT)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	Benzyl Alcohol (UNII: LKG8494WBH)
INGR	Coumarin (UNII: A4VZ22K1WT)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		10/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/27/2020

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-700) , LABEL(59448-700)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) LTD		672044552	MANUFACTURE(59448-700)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	MANUFACTURE(59448-700)