The DaVinci Company Lidocaine Ointment, USP 5%

The Davinci Company by

Drug Labeling and Warnings

The Davinci Company by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE DAVINCI COMPANY- lidocaine cream 
Inspec Solutions LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

The DaVinci Company Lidocaine Ointment, USP 5%

Active Ingredient

Lidocaine ............. 0.5%

Lidocaine 0.5% ............. Pain Reliever

Temporary relief of pain and itching due to

- sunburn - minor burn - insect bites - minor cuts - scraps

Warnings

For external use only

When using this product keep out of eyes

Rinse with warter to remove

Sop use and ask a doctor

system persist for more than 7 days.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Direction

Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day

Children under 2 years of age: consult a physician.

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

THE DAVINCI COMPANY 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
TRICAPRYLIN (UNII: 6P92858988)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ZINC OXIDE (UNII: SOI2LOH54Z)
MINERAL OIL (UNII: T5L8T28FGP)
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROCORTISONE (UNII: WI4X0X7BPJ)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-056-01	35 mL in 1 TUBE; Type 0: Not a Combination Product	10/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/25/2022

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-056)

Revised: 10/2022

Document Id: ebdf9de6-c8d7-1a4f-e053-2995a90a2d14

34390-5

Set id: ebdfb077-02fb-c47d-e053-2a95a90a743c

Version: 5

Effective Time: 20221025