Zylotrol Pain Relieving Cream

Zylotrol Pain Relieving Cream
SPL v3
SPL
SPL Set ID 2301fed7-0fa9-450d-8b1b-006f53235be0
Route
TOPICAL
Published
Effective Date 2024-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Water Medium-chain Triglycerides Isopropyl Palmitate Propanediol Glycerin Stearyl Alcohol Shea Butter Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Docosanol Edetol Glyceryl Monostearate Peg-100 Stearate Allantoin Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Avocado Oil Tamanu Oil Polysorbate 60 Aloe Vera Leaf Arnica Montana Flower Chamomile St. John's Wort Indian Frankincense Sodium Polyacrylate (2500000 Mw) Hydrogenated Polydecene (550 Mw) Trideceth-6 Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-29

Description

Lidocaine HCl 4.0% Menthol 1.0%

Purpose

Topical Analgesic, Anesthetic


Medication Information

Warnings and Precautions

Warnings 

For external use only.

Ask a doctor before use ifyou have a heart condition.

Do not use  if you are allergic to any other type of numbing medicine •in large quantities, particularly over raw surfaces or blistered areas on infections on deep puncture wounds •if pregnant or breastfeeding.

When using this product  do not use over large skin areas do not apply heat, bandages or plastic wrap to treated areas do not use in or near the eyes wash hands immediately after using.

Stop use and ask a doctor if  allergic reaction occurs •condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.

Indications and Usage

Uses

For temporarily relief of pain

Purpose

Topical Analgesic, Anesthetic

Dosage and Administration

Directions

Apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

Description

Lidocaine HCl 4.0% Menthol 1.0%

Section 50565-1

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

Section 51727-6

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water.

*Certified Organic Ingredient - Mayacert Certifier

Section 53413-1

Questions?

(310) 320-0100

Drug Facts 

Active Ingredients 

Lidocaine HCl 4.0%

Menthol 1.0%

Principal Display Panel Jar Label

Principal Display Panel Tube Label


Structured Label Content

Indications and Usage (34067-9)

Uses

For temporarily relief of pain

Dosage and Administration (34068-7)

Directions

Apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

Warnings and Precautions (34071-1)

Warnings 

For external use only.

Ask a doctor before use ifyou have a heart condition.

Do not use  if you are allergic to any other type of numbing medicine •in large quantities, particularly over raw surfaces or blistered areas on infections on deep puncture wounds •if pregnant or breastfeeding.

When using this product  do not use over large skin areas do not apply heat, bandages or plastic wrap to treated areas do not use in or near the eyes wash hands immediately after using.

Stop use and ask a doctor if  allergic reaction occurs •condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water.

*Certified Organic Ingredient - Mayacert Certifier

Section 53413-1 (53413-1)

Questions?

(310) 320-0100

Purpose

Topical Analgesic, Anesthetic

Drug Facts 

Active Ingredients  (Active ingredients )

Lidocaine HCl 4.0%

Menthol 1.0%

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

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


Advanced Ingredient Data


Raw Label Data

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