True Lido by Singular Dreamer, Ltd dba True Marker

True Lido by

Drug Labeling and Warnings

True Lido 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- lidocaine cream 
Singular Dreamer, Ltd dba True Marker

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Active Ingredient                                                          Purposes

Lidocaine 4.00% .....................................................Topical Analgesic

Uses

For the temporary relief of pain and itching, associated with minor burns, sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Warnings

  • For External Use only
  • Avoid contact with the eyes.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • Stop Use and Ask a Doctor ifcondition worsens or if symptoms persist for more than 7 days
    or occur again within a few days.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use,
consults a doctor.

Other Information

Store at room temperature, 20 – 25°C (68-77°F).

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.

Product label

image description

TRUE LIDO 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83035-1132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83035-1132-660 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/16/202411/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/16/202411/01/2024
Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 10/2024