MICROCAINE TOPICAL ANALGESIC- lidocaine cream

Microcaine Topical Analgesic by

Drug Labeling and Warnings

Microcaine Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Unit Dose, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Local Anesthetic

Uses:

Temporarily relieves pain from anorectal origin.

WARNINGS

For External Use only

When using this product

• Do not get into the eyes
• Do not use more than directed
• Do not swallow

Stop use and ask a doctor if

• pain worsens or does not improve within 7 days or clears up and appears again in a few days
• ​you develop an allergy

Keep out of reach of children

• If swallowed, get medical help right away or contact a Poison Control Center right away. NDC: 67194-022-01

Directions:

​Children under 12 years-ask a doctor

• Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.

Questions?

​Call toll free 888/452-4946

Inactive ingredients:

Water (Aqua), Prolatum Oil. Stearyl Alcohol, Polysorbate 60, Cetearyl Alcohol, Glyceryl Stearate, Carbomer, Triethanolamine, Propylparaben, Propylene Glycol, Methylparaben, Disodium EDTA, Diazolidinyl Carbamide, BHT

​Package Labeling:

INGREDIENTS AND APPEARANCE

MICROCAINE TOPICAL ANALGESIC 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67194-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67194-022-01	15 g in 1 JAR; Type 0: Not a Combination Product	01/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/19/2016

Labeler - Unit Dose, Ltd. (119080393)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose, Ltd.		119080393	relabel(67194-022)