True Lido Gel Patch by Singular Dreamer, Ltd dba True Marker

True Lido Gel Patch by

Drug Labeling and Warnings

True Lido Gel Patch by is a Otc medication manufactured, distributed, or labeled by Singular Dreamer, Ltd dba True Marker. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRUE LIDO GEL PATCH- lidocaine hcl patch 
Singular Dreamer, Ltd dba True Marker

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Active Ingredient                                                          Purposes

Lidocaine  4.00% .....................................................Topical Anesthetic

Uses

For the temporary relief of pain.

Warnings

• For External Use only
• Do not use: ● More than 1 patch at a time ● On wounds or damaged skin ● With a heating pad ● If you are allergic to any ingredients of this product
• When using this product: ● Use only as directed ● Avoid contact with eyes, mucous membranes or rashes ● Do not bandage tightly
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adult and children 12 years of age and over:

• Clean and dry affected area
• Remove film from patch and apply to the skin
• Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• Remove patch from the skin after at most 8-hour application
• Children under 12 years of age: Consult a doctor.

Other Information

• Store at controlled room temperature 20° - 25°C (68° - 77°F)
• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90,
Propylene glycol, Propylparaben, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water.

Questions or Comments

Call 1-(888) 811-2634

Product label

TRUE LIDO GEL PATCH 
lidocaine hcl patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-1131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83035-1131-1	15 in 1 BOX	05/28/2024	11/01/2024
1		1 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	05/28/2024	11/01/2024

Labeler - Singular Dreamer, Ltd dba True Marker (129504103)

Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 10/2024

Document Id: 251715ca-be23-c5c6-e063-6394a90aa5fa

34390-5

Set id: ecca22a9-8262-4c22-b87a-5ffd627b2598

Version: 3

Effective Time: 20241022