Lidocaine by Nivagen Pharmaceuticals, Inc. LIDOCAINE cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Nivagen Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs to ingredients in this product
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and return within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. 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°C (77°C); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

Questions?

1-877-977-0687

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC: 75834-141-30

Lidocaine 5%
Topical Anesthetic Cream-Anorectal

NIVAGEN
PHARMACEUTICALS

net wt. 30 g (1 oz)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75834-141
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75834-141-30	30 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/15/2016

Labeler - Nivagen Pharmaceuticals, Inc. (052032418)