​flanax

​flanax
SPL v2
SPL
SPL Set ID 46d33346-e582-4af1-b81a-feca7033dceb
Route
TOPICAL
Published
Effective Date 2021-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Glycerin Sodium Polyacrylate (2500000 Mw) Dihydroxyaluminum Aminoacetate Edetate Disodium Kaolin Titanium Dioxide Polysorbate 80 Propylene Glycol Tartaric Acid Polyacrylic Acid (250000 Mw) Povidone K90 Methylparaben Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-15

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporarily relieves minor pain

Section 42229-5

LONGER LASTING PAIN RELIEF

For back, neck, leg & arm pain relieving ointment on a breathable adhesive pad

Questions/Comments?

www.flanax.com

Call 1 888 779 2877 9AM-5PM EST

Distributed by: Belmora LLC

2011 Crystal Dr. Suite 400, Arlington, VA 22202

Section 50565-1

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

Warnings

For external use only.

Do not use if pouch is damaged or opened.

Do not use  • More than 1 patch on your body at a time or on cut, irritated or swollen skin  • On puncture wounds  • For more than one week without consulting a doctor

When using this product

• Use only as directed. Read and follow all directions and warnings on this pouch

• Rare cases of serious burns have been reported with products of this type

• Do not apply to wounds or damaged, broken or irritated skin

• Do not allow contact with the eyes and mucous membranes

• Do not bandage tightly or apply local heat (such as heating pads) to the area of use

• Do not use at the same time as other topical analgesics

• Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch

Stop use and ask a doctor if

• Condition worsens  • Redness is present  • Irritation develops

• Symptoms persist for more than 7 days or clear up and occur again within a few days

• You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

Adults and children over 12 years: • Clean and dry affected area  • Carefully remove backing film from patch  • Apply one patch to affected area  • Do not use more than 2 patches in 24 hours unless, directed by a doctor.

Children under 12 years: ask a doctor.

How to apply



• Remove backing from patch by firmly grasping both ends and gently pull backing to separate it in the middle.

• Carefully remove one portion of backing from patch and apply exposed portion of patch to affected area.

• Once exposed portion of patch is positioned, remove remaining backing to completely apply patch to affected area.

Drug Facts

Active Ingredients

Lidocaine 4%

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water


Structured Label Content

Uses

Temporarily relieves minor pain

Section 42229-5 (42229-5)

LONGER LASTING PAIN RELIEF

For back, neck, leg & arm pain relieving ointment on a breathable adhesive pad

Questions/Comments?

www.flanax.com

Call 1 888 779 2877 9AM-5PM EST

Distributed by: Belmora LLC

2011 Crystal Dr. Suite 400, Arlington, VA 22202

Section 50565-1 (50565-1)

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

Purpose

Topical Anesthetic

Warnings

For external use only.

Do not use if pouch is damaged or opened.

Do not use  • More than 1 patch on your body at a time or on cut, irritated or swollen skin  • On puncture wounds  • For more than one week without consulting a doctor

When using this product

• Use only as directed. Read and follow all directions and warnings on this pouch

• Rare cases of serious burns have been reported with products of this type

• Do not apply to wounds or damaged, broken or irritated skin

• Do not allow contact with the eyes and mucous membranes

• Do not bandage tightly or apply local heat (such as heating pads) to the area of use

• Do not use at the same time as other topical analgesics

• Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch

Stop use and ask a doctor if

• Condition worsens  • Redness is present  • Irritation develops

• Symptoms persist for more than 7 days or clear up and occur again within a few days

• You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

Adults and children over 12 years: • Clean and dry affected area  • Carefully remove backing film from patch  • Apply one patch to affected area  • Do not use more than 2 patches in 24 hours unless, directed by a doctor.

Children under 12 years: ask a doctor.

How to apply



• Remove backing from patch by firmly grasping both ends and gently pull backing to separate it in the middle.

• Carefully remove one portion of backing from patch and apply exposed portion of patch to affected area.

• Once exposed portion of patch is positioned, remove remaining backing to completely apply patch to affected area.

Drug Facts

Active Ingredients (Active ingredients)

Lidocaine 4%

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water


Advanced Ingredient Data


Raw Label Data

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