FDA Label for Vonaflex
View Indications, Usage & Precautions
Vonaflex Product Label
The following document was submitted to the FDA by the labeler of this product Cymbiotics, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 4%
Uses
For temporary relief of pain & inflammation
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.
Change In Heading As Requested After Review Of Draft
The Indications and Directions section was renameded to Dosage and Administration. This was noted as required 34068-7 This change was made on 7/21/2022 as directed.
07/26/22-- As per validation request, changed Directions to come under Dosage and Administration.
Warnings
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 o C (68 o - 77 o F),. Protect from freezing or storing in direct sunlight.
Inactive Ingredient
Arnica Montana flower 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
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