ZYLOTROL- lidocaine hcl 4%, menthol 1% gel

Zylotrol by

Drug Labeling and Warnings

Zylotrol by is a Otc medication manufactured, distributed, or labeled by Asclemed USA, Inc., ASCLEMED USA INC. DBA ENOVACHEM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of pain.

WARNINGS

Warnings

For external use only not intended for ingestion.

DO NOT USE

Do not use

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

WHEN USING

When using this product

• Avoid contact with the eyes.

ASK DOCTOR

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & 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.

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

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.

QUESTIONS

Questions?

(310) 320-0100

SPL UNCLASSIFIED SECTION

Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZYLOTROL 
lidocaine hcl 4%, menthol 1% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-145(NDC:81902-201)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76420-145-04	1 in 1 BOX	06/12/2022
1		118.3 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
OTC Monograph Drug	M017	06/12/2022

Labeler - Asclemed USA, Inc. (059888437)

Establishment
Name	Address	ID/FEI	Business Operations
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-145)