SARASOTA MEMORIAL AMENITY- alcohol 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.

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Sarasota Memorial Amenity Kit

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, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Manufactured by:
COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.

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.

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

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 - 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

SARASOTA
MEMORIAL
HEALTH CARE SYSTEM

Contents/Origins:

1.9 fl. oz. Hand Sanitizer
Toothbrush, Sleep Mask, Ear Plugs, Facial Tissue, Patient
Hand Hygiene Education Card, Paper Bag 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

SARASOTA
MEMORIAL
HEALTH CARE SYSTEM

Item #: SARASOTA01
Description: AMENITY KIT, SARASOTA
MEM WELCOME
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 KIT/CS
Carton #: XXX of XXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: XX x XX x XX CM
Assembled in China

Components Made in China:

Component Made in Thailand:

SARASOTA
MEMORIAL
HEALTH CARE SYSTEM

PRINCIPAL DISPLAY PANEL - Kit Label
SARASOTA MEMORIAL AMENITY 
alcohol and sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-600
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-600-0030 in 1 BOX10/08/2019
11 in 1 BAG
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 53 mL
Part 21 TUBE 10 g
Part 1 of 2
INSTANT HAND ANTISEPTIC 
alcohol gel
Product Information
Item Code (Source)NDC:59448-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-004-0153 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 FINALpart333E11/27/2018
Part 2 of 2
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/08/2019
Labeler - ASP Global, LLc (080361159)
Establishment
NameAddressID/FEIBusiness Operations
Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-600) , LABEL(59448-600)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-600)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-600)

Revised: 12/2022
Document Id: dcfee2b1-6c43-44bd-80c5-77b23d2e21a2
Set id: f5dda019-fcfd-4e99-89cc-e79e76b402e7
Version: 3
Effective Time: 20221215
 
ASP Global, LLc