VONAFLEX- lidocaine lotion lotion 
Cymbiotics, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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CY15-Vonaflex

Active Ingredient

Lidocaine 4%

Uses

For temporary relief of pain & inflammation

Uses

for temporary relief of pain & inflammation

Directions

Use only as directed. Adults & children 12 years or older: apply evenly to affected area not more than 3-4 x daily. For children under 12 years, consult with doctor for recommendations.

For External use only.

Do not use:on wounds, raw surfaces or blistered areas, with a heating pad, or if allergic to product ingredients

When using this product:Avoid eye contact; do not use excessive amounts; do not exceed recommended dosage unless directed by doctor; do not bandage applied area.

Stop and ask doctor if:an allergic reaction occurs; condition worsens or does not improve within 7 days.

If pregnant or breast-feeding:consult with doctor before use.

if swallowed, get medical help or contact a Poison Control Center.

Precautions Concerning Children

Keep out of reach of children.

Other Information:

Store at 20 o- 25 oC (68 o- 77 oF),. Protect from freezing or storing in direct sunlight.

Arnica Montanaflower extract, cetearyl alcohol, cetyl ester waxes, cyclopentasiloxane, disodium EDTA, ethoxydiglycol, fragrance, Helianthus annuus(sunflower) oil, Lavandula Angustifolio(lavender) oil, methylparaben, PEG40 hydrogenated caster oil, poly(acrylic acid) 2-propionic acid homopolymer, propylene glycol, propylparaben, tetrahydrocurcumin, tocopherol acetate, triethanolamine, water.

Questions and Comments

www.optimallabortories.com

(212) 535-1700

Package Label and Principal Display Panel Vonaflex

NDC 36590-6451-03 front & back label NDC-3690-6461-03

VONAFLEX 
lidocaine lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36590-6461
Route of AdministrationTOPICAL, CUTANEOUS, VAGINAL, RECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.02 g  in 100 g
WATER (UNII: 059QF0KO0R) 71.93 g  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI) 0.75 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.55 g  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8) 1 g  in 100 g
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 1 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4 g  in 100 g
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) 5 g  in 100 g
CETYL ESTERS WAX (UNII: D072FFP9GU) 4 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2 g  in 100 g
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03) 2 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 1.5 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1.2 g  in 100 g
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 0.4 g  in 100 g
FRAGRANCE LAVENDER ROSE ORC1004596 (UNII: 1XW43TV4PI) 0.1 g  in 100 g
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 0.25 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36590-6461-150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/25/2023
2NDC:36590-6461-275 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/25/2023
3NDC:36590-6461-3100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2022
4NDC:36590-6461-4150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2022
5NDC:36590-6461-5200 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/25/2022
Labeler - Cymbiotics, Inc (781766709)
Registrant - Westwood Laboratories, LLC (832280635)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories, LLC832280635manufacture(36590-6461) , label(36590-6461) , pack(36590-6461)

Revised: 11/2023
Document Id: 09bd5322-f4bd-ae4f-e063-6294a90a8509
Set id: dd30ccaf-d239-9d82-e053-2a95a90a6e84
Version: 3
Effective Time: 20231109
 
Cymbiotics, Inc