True Lido Cream by Singular Dreamer, Ltd dba True Marker / PURE SOURCE, LLC.

True Lido Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

TRUE LIDO CREAM- lidocaine hcl cream 
Singular Dreamer, Ltd dba True Marker

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Active Ingredient                                                          Purposes

Lidocaine HCL 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

TRUE LIDO CREAM 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-1130
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83035-1130-3	60 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/16/2024	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/16/2024	11/01/2024

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

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

Establishment
Name	Address	ID/FEI	Business Operations
PURE SOURCE, LLC.		080354456	manufacture(83035-1130)

Revised: 10/2024

Document Id: 25171e37-8a20-1ca9-e063-6394a90aadf8

34390-5

Set id: 1f160d87-6542-4974-9d76-e8912ad91211

Version: 3

Effective Time: 20241022