MERICAINE- lidocaine gel

Mericaine by

Drug Labeling and Warnings

Mericaine by is a Otc medication manufactured, distributed, or labeled by Merit Pharmaceutical, Biozone Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Lidocaine 4% Gel

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching due to:

• minor cuts
• minor scrapes
• sunburn
• minor skin irritations
• minor burns
• insect bites

Warnings

For external use only.  Not for ophthalmic use.

Do not use:

• in or near the eyes
• in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or does not improve within 7 days
• symptoms clear up and return within a few days
• redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years and older:  Apply externally to the affected area up to 3 to 4 times a day.
• Children under 2 years of age:  Consult a doctor.

Inactive Ingredients

alcohol, benzyl alcohol, carbomer, citric acid, ethoxydiglycol, propylene glycol, and purified water.

Other Information

• May be applied under occlusive dressing.
• Store at 25 ​0​C (77 ​0​F); excursions permitted to 15-30 ​0​C (59-86 ​0​F) [See USP Controlled Room Temperature].

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MERICAINE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30727-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30727-810-30	1 in 1 BOX	07/01/2016
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2015

Labeler - Merit Pharmaceutical (093370369)

Registrant - Merit Pharmaceutical (093370369)

Establishment
Name	Address	ID/FEI	Business Operations
Biozone Laboratories, Inc.		962455320	manufacture(30727-810) , analysis(30727-810) , pack(30727-810) , label(30727-810)