Goodsense Pain Relief Patch 5 Ct. Lidocaine 4% Zdp 838

Goodsense Pain Relief Patch 5 Ct. Lidocaine 4% Zdp 838
SPL v5
SPL
SPL Set ID 826f8da4-8468-ea0a-e053-2991aa0a66cb
Route
TOPICAL
Published
Effective Date 2019-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Polysorbate 80 Propylparaben Alcohol Dihydroxyaluminum Aminoacetate Anhydrous Sodium Polyacrylate (8000 Mw) Titanium Dioxide Water Kaolin Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-21

Description

Active ingredient Purpose Lidocaine 4%..................................................................Topical anesthetic.


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • adults and children over 12 years:
  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours
  • children 12 years or younger: ask doctor
Dosage and Administration

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

Made in China

Description

Active ingredient Purpose Lidocaine 4%..................................................................Topical anesthetic.

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Section 50567-7

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
  • dispose of used patch in matter that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Section 50570-1

Do not use

  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • at the same time as other topical analgesics
  • on puncture wounds
  • for more than one week without consulting a doctor
Section 51727-6

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Use

  • temporarily relieves minor pain
Section 55106-9

Active ingredient Purpose

Lidocaine 4%..................................................................Topical anesthetic.


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children over 12 years:
  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours
  • children 12 years or younger: ask doctor
Dosage and Administration (34068-7)

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Section 50567-7 (50567-7)

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
  • dispose of used patch in matter that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Section 50570-1 (50570-1)

Do not use

  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • at the same time as other topical analgesics
  • on puncture wounds
  • for more than one week without consulting a doctor
Section 51727-6 (51727-6)

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Use

  • temporarily relieves minor pain
Section 55106-9 (55106-9)

Active ingredient Purpose

Lidocaine 4%..................................................................Topical anesthetic.


Advanced Ingredient Data


Raw Label Data

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