LIDOCAINE by Sichuan Gumo Brand Management Co.,Ltd LIDOCAINE cream

LIDOCAINE by

Drug Labeling and Warnings

LIDOCAINE by is a Otc medication manufactured, distributed, or labeled by Sichuan Gumo Brand Management Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation

Warnings

Warnings ( For extemal use only )

When using this product

do not exceed the recommended daily dosage unless directed by a doctor.

certain persons can develop allergic reactions to ingredients in this product.

do not put this product into the rectum by using finger or any medical device or applicator.

Stop use

n/a

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Incase of accidental ingestion , seek medical attention immediately

Directions

Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product.

Apply up to 6 times a day,

Children up under 12 years of age: consult a doctor.

Other Information

keep away from direct sunlight or heata.

store in room temperature ( 59-86 F/15-30 C )

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83365-003
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83365-003-01	56 g in 1 BOX; Type 0: Not a Combination Product	04/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M015	04/21/2023

Labeler - Sichuan Gumo Brand Management Co.,Ltd (406945503)

Establishment
Name	Address	ID/FEI	Business Operations
Sichuan Gumo Brand Management Co.,Ltd		406945503	manufacture(83365-003)