LIDOCAINE 5%- lidocaine cream

Lidocaine 5% by

Drug Labeling and Warnings

Lidocaine 5% by is a Otc medication manufactured, distributed, or labeled by Apnar Pharma LP, Invaderm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5% w/w

PURPOSE

Local Anesthetic

Uses Temporarily relieves pain and itching due to anorectal disorders

WARNINGS

When using this product

• Avoid contact with eyes
• Do not exceed recommended dosage unless directed by a doctor

ASK DOCTOR

• Rectal bleeding occurs
• Condition worsens or does not improve within 7 days
• Allergic reaction occurs
• Redness, irritation, swelling, pain or other symptoms begin 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, clean 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 SAFETY INFORMATION

Store at room temperature 20-25°C (68-77°F); Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].

INACTIVE INGREDIENT

Benzyl Alcohol, Carbopol 940 (Carbomer 940), Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate (Alpha Tocophferol Acetate)

DOSAGE

50 miligrams/gram per application

USAGE

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

PRINCIPAL DISPLAY PANEL

NDC: 24689-124-01

Lidocaine 5% Anorectal Cream

Apnar Pharma LP

Net.Wt 30 grams

INGREDIENTS AND APPEARANCE

LIDOCAINE 5% 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-124
Route of Administration	RECTAL, 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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-124-01	1 in 1 CARTON	11/01/2021
1		30 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 Drug	M015	11/01/2021

Labeler - Apnar Pharma LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
Invaderm		078610697	analysis(24689-124) , manufacture(24689-124) , pack(24689-124)