LUBRICAINE- lidocaine 4% gel 
ESBA LABORATORIES INC.

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LUBRICAINE

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain and itching

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to affected area no more than 3 to 4 times a day

Other Information

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Citric Acid, Dehydroacetic Acid, Dipotassium Glycyrrhizinate, Lactic Acid, Natural Flavors, Potassium Sorbate, Purified Water, Stevia Rebaudiana Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Xanthan Gum.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am to 5 pm Eastern Time M-F or visit www.esbalabs.com

Label of tube of Lubricaine 113 g

LUBRICAINE 
lidocaine 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63135-727
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
LACTIC ACID, DL- (UNII: 3B8D35Y7S4) 3.5 g  in 100 g
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) 1 g  in 100 g
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) 1 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.5 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.54 g  in 100 g
DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.06 g  in 100 g
VANILLA (UNII: Q74T35078H) 1 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.3 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 3 g  in 100 g
CRANBERRY (UNII: 0MVO31Q3QS) 5 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) 0.4 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63135-727-04113 g in 1 TUBE; Type 0: Not a Combination Product09/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/03/2019
Labeler - ESBA LABORATORIES INC. (963303490)
Registrant - ESBA LABORATORIES INC. (963303490)

Revised: 9/2024
Document Id: 22824b46-53a3-6b19-e063-6394a90a18ad
Set id: 9d7416b1-607d-34e0-e053-2a95a90aa3c3
Version: 4
Effective Time: 20240919
 
ESBA LABORATORIES INC.