Zylotrol Plus by Whitestone Products LLC Zylotrol Plus

Zylotrol Plus by

Drug Labeling and Warnings

Zylotrol Plus by is a Otc medication manufactured, distributed, or labeled by Whitestone Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZYLOTROL PLUS- lidocaine 4%, menthol 1%, isopropyl alcohol 
Whitestone Products LLC

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Zylotrol Plus

Lidocaine 4% / Menthol 1% Patch

ACTIVE INGREDIENTS:

Lidocaine 4.00%

Menthol 1.00%

Topical Anesthetic

External Analgesic

USES:

For temporary relief of pain

WARNINGS:

• For external use only.
• Avoid contact with eyes.
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not use

• in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS (Adults and Children Over 12 Years):

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8 hours

Do not use patches for longer than five consecutive days,

Children under 12 should consult physician prior to use.

INACTIVE INGREDIENTS:

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

Store below 25 degrees Celsius, Avoid directe sunlight.

Isopropyl Alcohol 70% Prep Pads

Active ingredient

Isopropyl Alcohol 70% v/v

Purpose

First Aid 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
• Do not use in the eyes
• Do not apply to irritated skin

• Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

• Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Open packet
• Remove pad
• Apply topically as needed to cleanse intended area. Discard after single use.

Other information

• Store at room temperature 59-86°F (15-30°C)
• Contents sterile in unopened, undamaged package

Inactive ingredients

purified water

PRINCIPAL DISPLAY PANEL

NDC: 81902-202-15

Zylotrol TM Plus

Pacakge Contains:

15 Lidocaine 4%/ Menthol 1% Topical Analgesic Patches

15 Isopropyl Alcohol 70% Prep Pads

ZYLOTROL PLUS 
lidocaine 4%, menthol 1%, isopropyl alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81902-202

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81902-202-15	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	10/15/2021	10/04/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	15 PATCH	15 g
Part 2	15 PACKET	15 mL

Part 1 of 2

LIDOCAINE, MENTHOL 
lidocaine, menthol patch

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/16/2019	10/04/2023

Part 2 of 2

ISOPROPYL ALCOHOL 
isopropyl alcohol swab

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	04/09/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/15/2021	10/04/2023

Labeler - Whitestone Products LLC (118064415)

Revised: 10/2023

Document Id: 06f11d1a-812e-97d6-e063-6294a90af031

34390-5

Set id: 38bad3dd-cdaf-47a9-bbce-0a7b02492488

Version: 2

Effective Time: 20231005