Label: NEWYORK-PRESBYTERIAN AMENITY- sodium monofluorophospate kit
- NDC Code(s): 42555-060-45, 59448-100-00
- Packager: ASP Global, LLc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 10 g Tube Label
-
PRINCIPAL DISPLAY PANEL - Amenity Kit
NewYork-Presbyterian
We are pleased to
present this welcome kit
for your comfort and
convenience during your
stay.Thank you for choosing
New York-Presbyterian
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
0.85 oz. net wt. Soap Bar
Hair brush, Toothbrush, Ear plugs,
Sleep Mask and Kit Case:
Made in China
Toothpaste: Made in ThailandLawson #: 440016
Lot #:
Exp:Distributed by:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA440016-I-A REV 3
Amenity Kit - Adult
Made in China:
- Shampoo/Conditioner
- Body Wash
- Body Lotion
- Alcohol-Free Mouthwash
- Hair Brush
- Toothbrush
- Ear Plugs
- Facial Soap
- Lip Moisturizer
- Sleep Mask
- Kit Case
Made in Thailand:
- Toothpaste
REF#: 440016
QTY: 20 KIT/CS
GROSS
WEIGHT: 10.5 kgLOT #: XMMDDFC
EXP: YYYY-MM-DD
1
SINGLE
PATIENT
USENOT MADE
WITH
NATURAL
RUBBER
LATEXDISTRIBUTED BY:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USANewYork-Presbyterian
The University Hospital of Columbia and Cornell -
INGREDIENTS AND APPEARANCE
NEWYORK-PRESBYTERIAN AMENITY
sodium monofluorophospate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59448-100 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59448-100-00 1 in 1 BAG 07/01/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 10 g Part 2 1 TUBE 60 mL Part 3 1 TUBE 60 mL Part 4 1 TUBE 60 mL Part 5 1 TUBE 4.25 g Part 6 1 BOTTLE, PLASTIC 65 mL Part 7 1 CELLO PACK 28 g Part 1 of 7 COLGATE ANTICAVITY
sodium monofluorophosphate paste, dentifriceProduct 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 7 GILCHRIST AND SOAMES BODY BUTTER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 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 7 GILCHRIST AND SOAMES HAIR 2 IN 1
shampoos (non-coloring) shampooProduct 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 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 7 GILCHRIST AND SOAMES BODY REFRESHER--BODY WASH
skin fresheners liquidProduct 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 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 7 GILCHRIST AND SOAMES MOISTURIZING LIP BALM
lipstick lipstickProduct 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 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 07/01/2013 Part 6 of 7 ASP GLOBAL, LLC ALCOHOL-FREE
mouthwashes and breath fresheners (liquids and sprays) mouthwashProduct 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 Score Shape Size Flavor MINT Imprint Code Contains 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 Part 7 of 7 ASP GLOBAL, LLC CLEANSING GLYCERENE BAR
bath soaps and detergents soapProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Sodium Palmitate (UNII: JQ43KP6296) INGR Sodium Cocoate (UNII: R1TQH25F4I) INGR Water (UNII: 059QF0KO0R) INGR Glycerin (UNII: PDC6A3C0OX) INGR Sodium Chloride (UNII: 451W47IQ8X) INGR Palmitic Acid (UNII: 2V16EO95H1) INGR Edetic Acid (UNII: 9G34HU7RV0) INGR Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 CELLO PACK; 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 FINAL part355 07/01/2013 Labeler - ASP Global, LLc (080361159) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive (Thailand) LTD 672044552 MANUFACTURE(59448-100) Establishment Name Address ID/FEI Business Operations Shengzhou Kingbird Travel Products Co., Ltd. 560219293 PACK(59448-100) , LABEL(59448-100)