ENGLEWOOD MESH AMENITY- benzalkonium chloride and sodium monofluorophosphate 
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.

----------

Englewood Mesh Amenity Kit

Instant Hand Antiseptic

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.095%

Propose

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, Polyquaternium-37, Glycerin, Propylene Glycol, Methylisothiazolinone, Trithanolamine.

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

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, 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

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 - 53 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g
7
OTHER

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

PRINCIPAL DISPLAY PANEL - Kit Label

ENGLEWOOD
HEALTH

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, Comb, Deck of Playing Card,
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
HEALTH

Item #: ENGLWD2
Description: Amenity Kit,
Englewood Mesh

PO #:
Lot #:
XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: XX of XX
Net Wt.: XX.X KG
Gross Wt.: XX.X KG
Cubic Dimensions: XX x XX x XX CM

Assembled in China

Components Made in China:

Component Made in Thailand:

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Your hospital for life.

PRINCIPAL DISPLAY PANEL - Kit Label
ENGLEWOOD MESH AMENITY 
benzalkonium chloride and sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-401
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-401-0020 in 1 BOX06/13/2018
11 in 1 BAG
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 53 mL
Part 21 TUBE 10 g
Part 31 TUBE 59 mL
Part 41 TUBE 59 mL
Part 51 TUBE 59 mL
Part 61 TUBE 4.25 g
Part 71 BOTTLE, PLASTIC 65 mL
Part 81 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.095 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-002-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E06/01/2018
Part 2 of 8
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 3 of 8
GILCHRIST AND SOAMES   BODY BUTTER
cleansing (cold creams, cleansing lotions, liquids, and pads)
Product Information
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
colorWHITEC48325
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 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 8
GILCHRIST AND SOAMES   HAIR 2 IN 1
shampoos (non-coloring)
Product Information
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
colorYELLOWC48330
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 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 8
GILCHRIST AND SOAMES   BODY REFRESHER--BODY WASH
skin fresheners
Product Information
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
colorWHITEC48325
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC11/01/2016
Part 6 of 8
ENGLEWOOD   LIP BALM
lipstick
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRPOLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
INGRSHEANUT OIL (UNII: O88E196QRF)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
colorYELLOWC48330
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
COSMETIC06/13/2018
Part 7 of 8
ENGLEWOOD   ALCOHOL-FREE
mouthwashes and breath fresheners (liquids and sprays)
Product Information
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
colorBLUEC48333
flavorMINTC73404
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
COSMETIC06/13/2018
Part 8 of 8
GILCHRIST AND SOAMES 
deodorants (underarm)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPolyethylene Glycol 400 (UNII: B697894SGQ)  
INGRStearic Acid (UNII: 4ELV7Z65AP)  
INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
INGRSodium Hydroxide (UNII: 55X04QC32I)  
INGRWHITE WAX (UNII: 7G1J5DA97F)  
INGRStarch, Rice (UNII: 4DGK8B7I3S)  
INGRLavender Oil (UNII: ZBP1YXW0H8)  
INGRTannic Acid (UNII: 28F9E0DJY6)  
INGRSodium Lactate (UNII: TU7HW0W0QT)  
INGRButylene Glycol (UNII: 3XUS85K0RA)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRBenzyl Alcohol (UNII: LKG8494WBH)  
INGRCoumarin (UNII: A4VZ22K1WT)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
Product Characteristics
colorWHITEC48325
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC10/24/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E06/13/2018
Labeler - ASP Global, LLc (080361159)
Establishment
NameAddressID/FEIBusiness Operations
Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-401) , LABEL(59448-401) , REPACK(59448-401)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-401)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-401)

Revised: 10/2019
Document Id: 30b2b59c-de4c-452d-92b5-12c090f07524
Set id: a737fe63-6285-41ee-9516-9c3030a0ab48
Version: 3
Effective Time: 20191009
 
ASP Global, LLc