ULTRA LIDO GEL PATCH- lidocaine patch

Ultra Lido Gel Patch by

Drug Labeling and Warnings

Ultra 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]

Active Ingredient                                                          Purposes

Lidocaine 4.00% .....................................................Topical anesthetic

PURPOSE

Uses

For 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

Stop use and ask a doctor if:

• Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering ● Condition worsens
  ● Symptoms persist for more than 7 days ● Symptoms clear up and occur again within a few days

• 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.

KEEP OUT OF REACH OF CHILDREN

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

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycol Stearate,
Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil,Phenoxyethanol,Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid,
Triethanolamine.

SPL UNCLASSIFIED SECTION

Questions or Comments
Call 1-(888) 811-2634

Product label

INGREDIENTS AND APPEARANCE

ULTRA LIDO GEL PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-1137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	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: 83035-1137-1	15 in 1 BOX	07/18/2024
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	07/18/2024

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

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