VONAFLEX EFFECTIVE PAIN RELIEF TOPICAL ANALGESIC- lidocaine hydrochloride cream

VonaFlex Effective Pain Relief Topical Analgesic by

Drug Labeling and Warnings

VonaFlex Effective Pain Relief Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by OPTIMAL LABORATORIES, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Lidocaine hydrochloride 4%

Purpose

Topical Analgesic

Uses:

• For temporary relief of pain

Warnings:

For external use only

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 a thin layer to the affected area and massage until the lotion is no longer visible,  up to three times a day.
• 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:

Arnica Montana Extract, Caramel, Carbomer, Cetearyl Alcohol, Cetyl Esters, Disodium EDTA, Ethoxydiglycol, Ethyl Macadamiate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Flower Oil, Menthyl Lactate, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Scutellaria Baicalensis Root Extract, Tetrahydrodiferuloylmethane, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Package Labeling:

INGREDIENTS AND APPEARANCE

VONAFLEX EFFECTIVE PAIN RELIEF TOPICAL ANALGESIC 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87359-987
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CARAMEL (UNII: T9D99G2B1R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87359-987-00	1 in 1 BOX	12/23/2025
1		50 mL in 1 BOTTLE; 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	12/23/2025

Labeler - OPTIMAL LABORATORIES, LLC (107335682)

Registrant - Pure Source, LLC (080354456)