Wellstar Amenity Kit

SPL v4

SPL

SPL Set ID ced9dd96-7922-43d7-906f-32afaad733ec

Routes

TOPICAL DENTAL

Published

Effective Date 2022-12-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL) Fluoride Ion (7.6 mg)

Inactive Ingredients

Water Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine Dibasic Calcium Phosphate Dihydrate Sorbitol Sodium Lauryl Sulfate Sodium Pyrophosphate Saccharin Sodium

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-01

Description

Instant Hand Antiseptic Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Instant Hand Antiseptic Drug Facts

Use

helps protect against cavities

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 42229-5

Instant Hand Antiseptic

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

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.

Active Ingredient

Ethyl Alcohol 62%

Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

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.

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

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

Principal Display Panel 10 G Tube Label

P1505037

Colgate^®

Anticavity Toothpaste

Cavity

Protection

NET WT 10g

7

OTHER

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

Structured Label Content

Use

helps protect against cavities

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 42229-5 (42229-5)

Instant Hand Antiseptic

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

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.

Active Ingredient

Ethyl Alcohol 62%

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

Principal Display Panel Kit Label (PRINCIPAL DISPLAY PANEL - Kit Label)

Wellstar

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:

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

Principal Display Panel 10 G Tube Label (PRINCIPAL DISPLAY PANEL - 10 g Tube Label)

P1505037

Colgate^®

Anticavity Toothpaste

Cavity

Protection

NET WT 10g

7

OTHER

Principal Display Panel 53 Ml Bottle Label (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

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEANUT OIL", "unii": "O88E196QRF", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW", "unii": "", "classCode": "COLR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": 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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Lavender Oil", "unii": "ZBP1YXW0H8", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Tannic Acid", "unii": "28F9E0DJY6", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Lactate", "unii": "TU7HW0W0QT", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Butylene Glycol", "unii": "3XUS85K0RA", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Benzyl Alcohol", "unii": "LKG8494WBH", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Coumarin", "unii": "A4VZ22K1WT", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "INGR", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

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{"Use": "helps protect against cavities", "Uses": "For hand washing to decrease bacteria on the skin. Recommended for repeated use.", "42229-5": "Instant Hand Antiseptic Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.", "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.", "Active Ingredient": "Ethyl Alcohol 62%", "Active ingredient": "Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)", "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.", "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", "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", "PRINCIPAL DISPLAY PANEL - 10 g Tube Label": "P1505037 Colgate ® Anticavity Toothpaste Cavity Protection NET WT 10g 7 OTHER", "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"}

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Source: dailymed · Ingested: 2026-02-15T12:04:59.296035 · Updated: 2026-03-14T23:06:13.532900