LUBRICAINE 5- lidocaine 5% gel

LUBRICAINE 5 by

Drug Labeling and Warnings

LUBRICAINE 5 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 5%

Purpose

Anorectal Anesthetic

Warnings

For external use only.

Uses

For temporary relief of pain, soreness or burning in the perianal area

When using this product

Do not use this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product.

Stop use and ask a doctor if

• Certain persons can develop allergic reactions to ingredients in this product.
• If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
• Do not exceed the daily recommended dosage.
• In case of bleeding, consult a doctor promptly.
• As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
  

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

• Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
• Apply externally to the affected area up to 6 times daily.

Other Information

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

Inactive Ingredients

Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.

Questions

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUBRICAINE 5 
lidocaine 5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63135-924
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.72 g  in 100 g
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)	0.1 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z)	0.3 g  in 100 g
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)	1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	25 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T)	38.3 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	2 g  in 100 g
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.08 g  in 100 g
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)	2.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63135-924-04	113 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/20/2019

Labeler - ESBA LABORATORIES INC. (963303490)

Registrant - ESBA LABORATORIES INC. (963303490)

Establishment
Name	Address	ID/FEI	Business Operations
ESBA LABORATORIES INC.		963303490	manufacture(63135-924)