LIDOTRODE- lidocaine patch

Lidotrode by

Drug Labeling and Warnings

Lidotrode by is a Otc medication manufactured, distributed, or labeled by Strand Health Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Lidocaine 4%

PURPOSE

Local Anesthetic

USES

For the temporary relief of muscle pain and joint pain associated with:

-Backache -Neckache -Cramps -Soreness -Strains -Discomfort

WARNINGS: FOR EXTERNAL USE ONLY

ALLERGY ALERT

Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.

DO NOT USE

-On damaged, irritated, or infected skin

-If you are allergic to any ingredients in this product

-Otherwise as directed

WHEN USING THIS PRODUCT

Avoid contact with the eyes, nose, and mouth

STOP USE AND ASK DOCTOR IF

-Any of the warnings apply to you

-Excessive skin irritation develops

-Condition worses

IF PREGNANT OR BREASTFEEDING

Ask a healthcare professional before use

KEEP OUT OF REACH OF CHILDREN

If ingested, seek medical help or contact Poison Control immediately

FLAMMABLE

Keep away from excessive heat or open flame

DIRECTIONS

Adults and Children 12 Years of Age and Older:

-Clean and dry the affected area

-Apply gel pads directly to the skin for up to 12 hours

-One application of 4 pads per-day is recommended

-Wash hands immediately after use

OTHER INFORMATION

-Store in a cool, dry place with pouch tightly sealed. Keep from freezing.

INACTIVE INGREDIENTS

Aloe, Arnica, Magnesium, Polyacrylate, Vegan Glycerol

QUESTIONS OR COMMENTS

cs@strandhealthgroup.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOTRODE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83295-6400
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)
MAGNESIUM (UNII: I38ZP9992A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83295-6400-4	4 in 1 POUCH	08/24/2024
1		2.7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/24/2024

Labeler - Strand Health Group (118929144)