Zylotrol Pain Relieving Gel

Zylotrol Pain Relieving by

Drug Labeling and Warnings

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

Drug Details [pdf]

ZYLOTROL PAIN RELIEVING- lidocaine hydrochloride, menthol gel 
ASCLEMED USA INC. DBA ENOVACHEM

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Zylotrol Pain Relieving Gel

Drug Facts

Active ingredients

Lidocaine HCl 4.00 %

Menthol 1%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of pain.

Warnings:

For external use only not intended for ingestion.

Do not use

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

When using this product

  • Avoid contact with the eyes.

Stop use and ask a doctor if

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

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

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

Other information:

  • Store at 20-25°C (68-77°F) and protect from moisture.

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?

(310) 320-0100

Package Labeling:

Label

ZYLOTROL PAIN RELIEVING 
lidocaine hydrochloride, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76420-206
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76420-206-00118.3 mL in 1 TUBE; Type 0: Not a Combination Product08/10/202108/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/10/202108/18/2021
Labeler - ASCLEMED USA INC. DBA ENOVACHEM (059888437)

Revised: 8/2021
Document Id: c9d30967-768a-dd77-e053-2995a90a3bbb
Set id: e7c85e07-9b0d-40f1-8c5b-68be5419fb93
Version: 2
Effective Time: 20210818