Lidall Pain Relieving Patch

Lidall Pain Relieving Patch
SPL v4
SPL
SPL Set ID daba204e-2e7a-44ab-a692-088303c90af5
Route
TOPICAL
Published
Effective Date 2014-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Menthol (1 g)
Inactive Ingredients
Aloe Diazolidinyl Urea Edetic Acid Edetate Disodium Glycerin Iodopropynyl Butylcarbamate Methylparaben Polysorbate 80 Propylparaben Sodium Polyacrylate (8000 Mw) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-01

Description

For external use only Do not use ■ other than directed  ■ on wounds  ■ on damaged skin ■if you are allergic to menthol  ■ in large quantities, particularly over raw services or blistered areas When using this product ■ avoid contact with the eyes or mucous membranes ■ do not bandage tightly Stop use and ask a doctor ■ excessive irritation of the skin develops  ■ condition worsens ■symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

Purpose

Pain relief


Medication Information

Purpose

Pain relief

Description

For external use only Do not use ■ other than directed  ■ on wounds  ■ on damaged skin ■if you are allergic to menthol  ■ in large quantities, particularly over raw services or blistered areas When using this product ■ avoid contact with the eyes or mucous membranes ■ do not bandage tightly Stop use and ask a doctor ■ excessive irritation of the skin develops  ■ condition worsens ■symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

Use

■For the temporary relief of pain and itching associated with minor skin irritations.

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4

Warnings

For external use only

Do not use

■ other than directed

 ■ on wounds

 ■ on damaged skin

■if you are allergic to menthol

 ■ in large quantities, particularly over raw services or blistered areas

When using this product

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

Stop use and ask a doctor

■ excessive irritation of the skin develops

 ■ condition worsens

■symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Directions

Directions

■Clean and dry affected area. Cut open pouch and remove patch.

■Remove protective film and apply directly to affected area.

■Wash hands with soap after applying patch.

■Reseal pouch containing unused patches.

■Adults and children 12 years of age and older: Apply to affected area; change patch 1 to 2 times daily. Do not apply

to affected are more than 3 times daily.

■Children under 12 years of age: Consult a physician before use.

Other Information

Store below 77 º F (25º C). Avoid direct sunlight.

Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Aloe (Aloe Barbadensis) Leaf Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, Iodopropynyl Butylcarbamate,

Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, Water


Structured Label Content

Use

■For the temporary relief of pain and itching associated with minor skin irritations.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

Pain relief

Warnings

For external use only

Do not use

■ other than directed

 ■ on wounds

 ■ on damaged skin

■if you are allergic to menthol

 ■ in large quantities, particularly over raw services or blistered areas

When using this product

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

Stop use and ask a doctor

■ excessive irritation of the skin develops

 ■ condition worsens

■symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Directions

Directions

■Clean and dry affected area. Cut open pouch and remove patch.

■Remove protective film and apply directly to affected area.

■Wash hands with soap after applying patch.

■Reseal pouch containing unused patches.

■Adults and children 12 years of age and older: Apply to affected area; change patch 1 to 2 times daily. Do not apply

to affected are more than 3 times daily.

■Children under 12 years of age: Consult a physician before use.

Other Information (Other information)

Store below 77 º F (25º C). Avoid direct sunlight.

Active Ingredients (Active ingredients)

Lidocaine 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Aloe (Aloe Barbadensis) Leaf Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, Iodopropynyl Butylcarbamate,

Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, Water


Advanced Ingredient Data


Raw Label Data

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