Rugby Pain Relief Patches

Rugby Pain Relief Patches
SPL v8
SPL
SPL Set ID b34e40c8-a257-46cf-9399-f55df9b4102d
Route
TOPICAL
Published
Effective Date 2019-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Glycerin Aluminum Kaolin Methylparaben Polyacrylic Acid (300000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Povidone, Unspecified Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-01

Description

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Indications and Usage

Uses: Temporaily relieves minor pains.

Purpose

Temporarily relieves minor pain.

Dosage and Administration

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 one patch for up to 12 hours. Children under 12 years of age: consult a physician.


Medication Information

Indications and Usage

Uses: Temporaily relieves minor pains.

Purpose

Temporarily relieves minor pain.

Dosage and Administration

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 one patch for up to 12 hours. Children under 12 years of age: consult a physician.

Description

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only

Questions

TOLL-FREE

Customer Care Help Line

866-445-2158

DISTRIBUTED BY RUGBY HEALTH

Livonia, MI 48152



Made in China

Directions

Directions Adults and children 12 years of age and over:

■ clean and dry affected area

■ carefully remove backing from patch starting at a corner

■ apply sticky side of patch to affected area

■ use one patch for up to 12 hours.

  • Discard patch after single use
  • Children under 12 years of age: consult a physician.
Do Not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Do Not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Active Ingredient

Lidocaine 4.0%

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Inactive Ingredients

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,

Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

When Using This Product

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

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

■ do not microwave

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

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

If Pregnant Or Breastfeeding

ask a health professional before use

Stop Use and Consult A Doctor

■ 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.

Keep Out of Reach of Children and Pets

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

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Temporarily relieves minor pain.

Warnings

For external use only

Questions

TOLL-FREE

Customer Care Help Line

866-445-2158

DISTRIBUTED BY RUGBY HEALTH

Livonia, MI 48152



Made in China

Directions

Directions Adults and children 12 years of age and over:

■ clean and dry affected area

■ carefully remove backing from patch starting at a corner

■ apply sticky side of patch to affected area

■ use one patch for up to 12 hours.

  • Discard patch after single use
  • Children under 12 years of age: consult a physician.
Do Not Use (Do not Use)

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Do Not Use (Do not use)

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Active Ingredient

Lidocaine 4.0%

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Inactive Ingredients

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,

Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Indications and Usage

Uses: Temporaily relieves minor pains.

When Using This Product (When using this product)

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

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

■ do not microwave

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

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Other Safety Information (Other safety information)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Dosage and Administration

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 one patch for up to 12 hours. Children under 12 years of age: consult a physician.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use

Stop Use and Consult A Doctor (Stop use and consult a doctor)

■ 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.

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

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

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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


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