ZYLOTROL PAIN RELIEVING- lidocaine hcl, menthol cream

ZYLOTROL PAIN RELIEVING by

Drug Labeling and Warnings

ZYLOTROL PAIN RELIEVING 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]

Drug Facts 

Active ingredients 

Lidocaine HCl 4.0%

Menthol 1.0%

Purpose

Topical Analgesic, Anesthetic

INDICATIONS & USAGE

Uses

For temporarily relief of pain

WARNINGS

Warnings 

For external use only.

Ask a doctor before use ifyou have a heart condition.

Do not use if you are allergic to any other type of numbing medicine in large quantities, particularly over raw surfaces or blistered areas on infections on deep puncture wounds if pregnant or breastfeeding.

When using this product do not use over large skin areas do not apply heat, bandages or plastic wrap to treated areas do not use in or near the eyes wash hands immediately after using.

Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water.

*Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

Questions?

(310) 320-0100

Label

INGREDIENTS AND APPEARANCE

ZYLOTROL PAIN RELIEVING 
lidocaine hcl, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-560(NDC:81902-230)
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 - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DOCOSANOL (UNII: 9G1OE216XY)
EDETOL (UNII: Q4R969U9FR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALLANTOIN (UNII: 344S277G0Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
AVOCADO OIL (UNII: 6VNO72PFC1)
TAMANU OIL (UNII: JT3LVK84A1)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CHAMOMILE (UNII: FGL3685T2X)
ST. JOHN'S WORT (UNII: UFH8805FKA)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76420-560-04	102 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2023
2	NDC: 76420-560-02	102 g in 1 JAR; Type 0: Not a Combination Product	10/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/29/2022

Labeler - Asclemed USA, Inc. (059888437)

Establishment
Name	Address	ID/FEI	Business Operations
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-560)