rugby pain relief patches

rugby pain relief patches
SPL v2
SPL
SPL Set ID 975031df-d46d-4098-b1c0-1c0c92b41995
Route
topical
Published
Effective Date 2025-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
dihydroxyaluminum aminoacetate anhydrous glycerin 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

Purpose

Topical anesthetic

Description

Lidocaine 4.0%


Medication Information

Warnings

For external use only.

Purpose

Topical anesthetic

Directions

Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Description

Lidocaine 4.0%

Principal Display Panel

NDC 55154-7813-5

LIDOCAINE PATCH 4%

MAXIMUM OTC STRENGTH

5 PATCHES

.

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercream®.

Distributed by:

RUGBY® LABORATORIES

Undianapolis, IN 46268

Made in China

Questions or comments?

Call 1-800-616-2471

www.majorpharmaceuticals.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L59206240624

Rev. 12/23

R-153

Re-order No. 371082

Use

Temporarily es minor pain.

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%

Questions Or Comments?

Call 1-866-326-1313

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.

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 800-222-1222 right away.


Structured Label Content

Warnings

For external use only.

Purpose

Topical anesthetic

Directions

Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

NDC 55154-7813-5

LIDOCAINE PATCH 4%

MAXIMUM OTC STRENGTH

5 PATCHES

.

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercream®.

Distributed by:

RUGBY® LABORATORIES

Undianapolis, IN 46268

Made in China

Questions or comments?

Call 1-800-616-2471

www.majorpharmaceuticals.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L59206240624

Rev. 12/23

R-153

Re-order No. 371082

Use

Temporarily es minor pain.

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%

Questions Or Comments? (Questions or comments?)

Call 1-866-326-1313

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 (Other safety information)

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

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 800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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