WELLSTAR AMENITY- benzalkonium chloride and sodium monofluorophosphate kit

Wellstar Amenity by

Drug Labeling and Warnings

Wellstar 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

Wellstar

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 00

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

7
OTHER

PRINCIPAL DISPLAY PANEL - Kit Label

Wellstar

Item #: WSHKIT02
Description: AMENITY KIT, WELLSTAR
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: XXX of XXXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: 65.0 x 20.0 x 33.0 CM

Assembled in China

Components Made in China:

• Hand Sanitizer
• Alcohol-Free Mouthwash
• Lip Balm
• Toothbrush
• Hairbrush
• Body Lotion
• Body Wash
• Shampoo/Conditioner
• Deodorant Stick
• Facial Tissue
• Nail File
• Pen
• Notepad
• Kit Case

Component Made in Thailand:

• Toothpaste

WSHKIT02-MC-00

Wellstar

Contents/Origins:

2.0 fl. oz. Shampoo/Conditioner
2.0 fl. oz. Body Wash
2.0 fl. oz. Body Lotion
2.0 fl. oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
0.5 oz. net wt. Deodorant Stick
1.9 fl. oz. Hand Sanitizer

Toothbrush, Hairbrush, Facial Tissue, Nail File, Pen, Notepad,
and Kit Case: Made in China
Toothpaste: Made in Thailand

Lot #:
Exp:

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

REV 00

Wellstar

INGREDIENTS AND APPEARANCE

WELLSTAR AMENITY 
benzalkonium chloride and sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-800

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-800-00	20 in 1 BOX	10/01/2021
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 
alcohol gel

Product Information
Item Code (Source)	NDC: 59448-008
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: 59448-008-01	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	10/01/2021

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--LOTION
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--SHAMPOO-CONDITIONER
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

WELLSTAR  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

ASP GLOBAL  ALCOHOL-FREE MOUTHWASH
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	10/01/2021

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-800) , LABEL(59448-800)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) LTD		672044552	MANUFACTURE(59448-800)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	MANUFACTURE(59448-800)