Cy15-vonaflex

Cy15-vonaflex
SPL v5
SPL
SPL Set ID dd30ccaf-d239-9d82-e053-2a95a90a6e84
Routes
TOPICAL CUTANEOUS VAGINAL RECTAL
Published
Effective Date 2022-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.2 g)
Inactive Ingredients
Methylparaben Edetate Disodium Propylparaben Water Sunflower Oil Carbomer 940 Lavender Oil Polyoxyl 40 Hydrogenated Castor Oil Propylene Glycol Diethylene Glycol Monoethyl Ether Cetyl Esters Wax Cetostearyl Alcohol Tetrahydrodiferuloylmethane Trolamine .alpha.-tocopherol Acetate Cyclomethicone 5 Fragrance Lavender Rose Orc1004596 Arnica Montana Flower Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-08-25

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

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.

Description

Lidocaine 4%

Uses

For temporary relief of pain & inflammation

Section 51727-6

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.

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.

Active Ingredient

Lidocaine 4%

Other Information:

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

Questions and Comments

www.optimallabortories.com

(212) 535-1700

Precautions Concerning Children

Keep out of reach of children.

Package Label and Principal Display Panel Vonaflex

NDC 36590-6451-03 front & back label

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.


Structured Label Content

Uses

For temporary relief of pain & inflammation

Warnings and Precautions (34071-1)

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.

Section 51727-6 (51727-6)

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.

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.

Active Ingredient

Lidocaine 4%

Other Information:

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

Questions and Comments

www.optimallabortories.com

(212) 535-1700

Precautions Concerning Children

Keep out of reach of children.

Package Label and Principal Display Panel Vonaflex

NDC 36590-6451-03 front & back label

Change in Heading As Requested After Review of Draft (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.


Advanced Ingredient Data


Raw Label Data

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