BAYLOR SCOTT AND WHITE HYBRID COMFORT- benzalkonium chloride kit

Baylor Scott and White Hybrid Comfort by

Drug Labeling and Warnings

Baylor Scott and White Hybrid Comfort by is a Otc medication manufactured, distributed, or labeled by ASP Global, LLc, Shengzhou Kingbird Travel Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

for preparation of the skin prior to an injection.

Warnings

For external use only. Flammable, keep away from fire or flame. Do not use with electrocautery procedures or near eyes. 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

Apply topically as needed to clean intended area. Discard after single use.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Ethylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Sodium Citrate, Water

PRINCIPAL DISPLAY PANEL - Kit Label

BaylorScott&White
HEALTH

Item #: BSWHYB01
Description: KIT, BAYLOR SCOTT & WHITE HYBRID COMFORT

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

Made in China

Components:

• Hand/Body Lotion
• Lip Balm
• Sleep Mask
• Ear Plugs
• Puzzle Book
• Care Book
• Door Hanger
• Playing Cards
• Pen
• Hair Brush
• Stress Ball
• Hand Sanitizing Wipes
• Kit Case

For your comfort and healing, we hope to
make your hospital experience as quiet and
peaceful as possible. While it is not always
feasible to stop all noise as we actively care
for our patients, it is our priority to keep noise
levels low, especially at night. If we are not
meeting your expectations, please let us know.
Thank you for trusting Baylor Scott & White
with your care!

BaylorScott&White
HEALTH

Contents/Origins:

2.0 fl. oz. Hand/Body Lotion
0.15 oz. net wt. Lip Balm
Sleep Mask, Ear Plugs, Puzzle Book, Care Book, Door
Hanger, Playing Cards, Pen, Hair Brush, Stress Ball,
Hand Sanitizing Wipes, and Kit Case: Made in China

Lot #:
Exp:

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

BaylorScott&White
HEALTH

REV 00

BaylorScott&White
HEALTH

PRINCIPAL DISPLAY PANEL - 6.2 g Applicator Label

BaylorScott&White
HEALTH

OPEN

INGREDIENTS AND APPEARANCE

BAYLOR SCOTT AND WHITE HYBRID COMFORT 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59448-900

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-900-00	1 in 1 BAG	03/15/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 APPLICATOR	6.2 g
Part 2	1 TUBE	60 mL
Part 3	1 TUBE	4.25 g

Part 1 of 3

BENZALKONIUM CHLORIDE 
benzalkonium chloride cloth

Product Information
Item Code (Source)	NDC: 59448-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59448-010-01	10 in 1 PACKAGE
1		6.2 g in 1 APPLICATOR; 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	02/28/2022

Part 2 of 3

BAYLOR SCOTT WHITE   BODY
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PETROLATUM (UNII: 4T6H12BN9U)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
INGR	HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)

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		03/15/2022

Part 3 of 3

ASP GLOBAL   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	WHITE	C48325

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		11/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/15/2022

Labeler - ASP Global, LLc (080361159)

Establishment
Name	Address	ID/FEI	Business Operations
Shengzhou Kingbird Travel Products Co., Ltd.		560219293	PACK(59448-900)