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 2022-06-12

Medication Information

Warnings and Precautions

Warnings

For external use only not intended for ingestion.

Active Ingredient

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

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 42229-5

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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 60561-8

Other information

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only not intended for ingestion.

Active Ingredient (55106-9)

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

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.

Section 42229-5 (42229-5)

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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 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.", "42229-5": "Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501", "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."}