Lidocaine 5% by TriMarc Labs LIDOCAINE 5% cream

Lidocaine 5% by

Drug Labeling and Warnings

Lidocaine 5% by is a Otc medication manufactured, distributed, or labeled by TriMarc Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Use

temporarily relieves pain and itching due to anorectal disorders

WARNINGS:

For external use only

When using this product

• avoid contact with the eyes
• do not use in large quantities, particularly over raw surfaces or blistered areas
• do not put directly in rectum by using fingers or mechanical device
• do not exceed recommended dosage unless directed by a doctor

Stop use and ask doctor if:

• allergic reaction occurs
• rectal bleeding 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 the reach of children

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

Directions

• When practical, clean area with mild soap and warm water and rinse thouroughly
• Gently dry by patting or blotting with toilet tissue or soft cloth before applying
• Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
• Children under 12 years of age: Consult a doctor

Other Information

• Store at 25  deg. C (77F); excursions permitted to 15-30 deg. C (59-86F)

  [see USP Controlled Room Temperature].

Inactive ingredients

water, cetyl alcohol, stearic acid, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil,

lecithin, hexylene glycol, sodium polyacrylate, caprylyl glycol, ethoxydiglycol, potassium sorbate, phenoxyethanol

Lidocaine 5%

INGREDIENTS AND APPEARANCE

LIDOCAINE 5% 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68752-015
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
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68752-015-45	1 in 1 CARTON	04/29/2013
1		45 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
OTC monograph not final	part348	10/01/2011

Labeler - TriMarc Labs (156893695)

Registrant - TriMarc Labs (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
TriMarc Labs		156893695	manufacture(68752-015)