ZYLOTROL- lidocaine hcl 4%, menthol 1% gel 
Whitestone Products LLC

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Zylotrol

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain.

Warnings

For external use only not intended for ingestion.

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

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

Directions

Other information

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

box

ZYLOTROL 
lidocaine hcl 4%, menthol 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81902-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
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:81902-201-041 in 1 BOX01/04/2022
1118.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/04/2022
Labeler - Whitestone Products LLC (118064415)

Revised: 10/2023
Document Id: 07cf1076-0948-5b74-e063-6294a90a2396
Set id: 0e32e9c0-ff5b-4e88-89b1-f5903cd98209
Version: 3
Effective Time: 20231016
 
Whitestone Products LLC