LUBRICAINE- lidocaine 4% gel

LUBRICAINE by

Drug Labeling and Warnings

LUBRICAINE by is a Otc medication manufactured, distributed, or labeled by ESBA LABORATORIES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• do not use in or near the eye
• do not use in large quantities, particularly over raw surfaces or blistered areas
• do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or does not improve within seven days
• symptoms clear up and return within a few days
• you notice any unusual effects

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

• Store at room temperature 20-25 oC (68-77 oF)
• Tamper evident: do not use if foil under cap is damaged or mising.
• Child-Resistant Cap: push down and turn to open

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUBRICAINE 
lidocaine 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63135-727
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
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
CRANBERRY (UNII: 0MVO31Q3QS)	5 g  in 100 g
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
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
ALLANTOIN (UNII: 344S277G0Z)	0.4 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63135-727-04	113 g in 1 TUBE; Type 0: Not a Combination Product	09/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	09/03/2019

Labeler - ESBA LABORATORIES INC. (963303490)

Registrant - ESBA LABORATORIES INC. (963303490)

Establishment
Name	Address	ID/FEI	Business Operations
ESBA LABORATORIES INC.		963303490	manufacture(63135-727)