Flanax Back Pain Relief Patch

Flanax Back Pain Relief Patch
SPL v2
SPL
SPL Set ID af4bf57c-f250-4506-83eb-e0f253e96062
Route
TOPICAL
Published
Effective Date 2020-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Polyacrylic Acid (8000 Mw) Propylene Glycol Propylparaben Povidone, Unspecified Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-01

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

LIDOCAINE PATCH

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

 1 Patch | 3-15/16” x 5-1/2” (10 cm x 14 cm)

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.

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

​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.

Active Ingredients

Lidocaine 4%

Inactive Ingredients

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate,

tartaric acid, titanium dioxide, tween 80, water


Structured Label Content

Uses

 Temporarily relieves minor pain

Section 42229-5 (42229-5)

LONGER LASTING PAIN RELIEF

LIDOCAINE PATCH

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

 1 Patch | 3-15/16” x 5-1/2” (10 cm x 14 cm)

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

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

​warnings (​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.

Active Ingredients (Active ingredients)

Lidocaine 4%

Inactive Ingredients

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate,

tartaric acid, titanium dioxide, tween 80, water


Advanced Ingredient Data


Raw Label Data

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