Zylotrol

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (4 g)

Inactive Ingredients

Aloe Vera Leaf Water Arnica Montana Flower Indian Frankincense Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Isopropyl Alcohol Phenoxyethanol Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-01-04

Medication Information

Warnings and Precautions

Warnings

For external use only not intended for ingestion.

Indications and Usage

Uses

For the temporary relief of pain.

Dosage and Administration

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
Children under 2 years of age: consult a doctor.

Description

Active Ingredients Lidocaine HCl 4% Menthol 1%

Section 50565-1

Keep out of reach of children.

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

Section 50567-7

When using this product

Avoid contact with the eyes.

Section 50569-3

Stop use and ask a doctor if

condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.

Section 50570-1

Do not use

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

Section 51727-6

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine.

Section 51945-4

Section 53413-1

Questions?

(310) 320-0100

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Section 60561-8

Other information

Store at 20-25 ^oC (68-77 ^oF) and protect from moisture.

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of pain.

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
Children under 2 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only not intended for ingestion.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50567-7 (50567-7)

When using this product

Avoid contact with the eyes.

Section 50569-3 (50569-3)

Stop use and ask a doctor if

condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.

Section 50570-1 (50570-1)

Do not use

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

Section 51727-6 (51727-6)

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

(310) 320-0100

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Section 60561-8 (60561-8)

Other information

Store at 20-25 ^oC (68-77 ^oF) and protect from moisture.

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "INDIAN FRANKINCENSE", "unii": "4PW41QCO2M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of pain.", "34068-7": "Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily. Children under 2 years of age: consult a doctor.", "34071-1": "Warnings For external use only not intended for ingestion.", "50565-1": "Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Central right away.", "50567-7": "When using this product Avoid contact with the eyes.", "50569-3": "Stop use and ask a doctor if condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.", "50570-1": "Do not use in large quantities, particularly over raw surfaces, or blistered areas.", "51727-6": "Inactive ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine.", "53413-1": "Questions? (310) 320-0100", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Topical Analgesic", "55106-9": "Active Ingredients Lidocaine HCl 4% Menthol 1%", "60561-8": "Other information Store at 20-25 o C (68-77 o F) and protect from moisture."}