ENGLEWOOD AMENITY- benzalkonium chloride and sodium monofluorophosphate kit

Englewood Amenity by

Drug Labeling and Warnings

Englewood 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

Benzalkonium Chloride 0.095%

Purpose

Antiseptic

Uses

To help reduce bacteria on hands.

Warnings

For external use only.

When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Rub dime sized amount between hands until dry.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Polyquatemium-37, Glycerin, Propylene Glycol, Methylisothiazolinone, Trithanolamine.

SPL UNCLASSIFIED SECTION

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

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 - 53 mL Bottle Label

ENGLEWOOD
HEALTH

Instant Hand Antiseptic

Alcohol & Fragrance Free

1.9 FL OZ / 53 mL

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331
Rev 02

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

Colgate®
Anticavity Toothpaste

Cavity
Protection

PRINCIPAL DISPLAY PANEL - Kit Label

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Your hospital for life.

Contents/Origins:

2.0 fl.oz. G&S Shampoo/Conditioner
2.0 fl.oz. G&S Body Wash
2.0 fl.oz. G&S Body Lotion
2.0 fl.oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
0.1oz. G&S Deodorant
1.9 fl.oz. Alcohol-Free Hand Sanitizer
Toothbrush Case, Toothbrush, Hairbrush, Nail File, Eye Mask,
Ear Plugs, Ear Phones, and Kit Case: Made in China
Toothpaste: Made in Thailand

Lot #: XMMDDFC Exp: YYYY-MM-DD

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway, Atlanta, GA 30331
REV 00

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Item #: ENGLWD11
Description: Amenity Kit, Englewood

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
• Lip Balm
• Deodorant
• Alcohol-Free Hand Sanitizer
• Toothbrush Case
• Toothbrush
• Hairbrush
• Nail File,
• Eye Mask,
• Ear Plugs
• Ear Phones
• Kit Case

Component Made in Thailand:

• Toothpaste

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Your hospital for life.

INGREDIENTS AND APPEARANCE

ENGLEWOOD AMENITY 
benzalkonium chloride and sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-400

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-400-00	20 in 1 BOX	06/13/2018
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	59 mL
Part 5	1 TUBE	59 mL
Part 6	1 TUBE	4.25 g
Part 7	1 BOTTLE, PLASTIC	65 mL
Part 8	1 BOTTLE, WITH APPLICATOR	14 g

Part 1 of 8

INSTANT HAND ANTISEPTIC 
benzalkonium chloride gel

Product Information
Item Code (Source)	NDC: 59448-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.095 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Methylisothiazolinone (UNII: 229D0E1QFA)
Trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-002-01	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	06/01/2018

Part 2 of 8

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 8

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	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 4 of 8

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

Product Information

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 5 of 8

GILCHRIST AND SOAMES  BODY REFRESHER--BODY WASH
skin fresheners

Product Information

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	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		11/01/2016

Part 6 of 8

ENGLEWOOD  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	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		06/13/2018

Part 7 of 8

ENGLEWOOD  ALCOHOL-FREE
mouthwashes and breath fresheners (liquids and sprays)

Product Information

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		06/13/2018

Part 8 of 8

GILCHRIST AND SOAMES   DEODORANT
deodorants (underarm)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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)

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	06/13/2018

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-400) , LABEL(59448-400) , REPACK(59448-400)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) LTD		672044552	MANUFACTURE(59448-400)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	MANUFACTURE(59448-400)