Lidocaine by Nanjing Cuccess Pharmaceutical Co., Ltd. LIDOCAINE cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Nanjing Cuccess Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external only.

When using this product

• avoid contact with eyes
• 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
• symptoms 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 eyternally to the attected area un to 6 times a day.
• Children under 12 years of age: consult a doctor.

Other information

Store at USP controlled room temperature 20-25℃ (68-77°F).

Inactive ingredient

benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83589-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1.2 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83589-301-01	1 in 1 BOX	04/04/2024
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83589-301-03	1 in 1 BOX	04/04/2024
2		120 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 83589-301-02	1 in 1 BOX	04/04/2024
3		25 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	04/04/2024

Labeler - Nanjing Chengong Pharmaceutical Co., Ltd. (420793416)

Registrant - Nanjing Chengong Pharmaceutical Co., Ltd. (420793416)