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]

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

Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water   

Questions?

1-877-977-0687

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC: 75834-333-30

Lidocaine 5%

Topical Anesthetic Cream-Anorectal

NIVAGEN

net wt. 30 g (1 oz) 

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75834-333
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
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (WHITE TO OFF WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75834-333-30	30 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M015	01/05/2025

Labeler - Nivagen Pharmaceuticals, Inc. (052032418)