LIDOCAINE- lidocaine cream 
Sichuan Gumo Brand Management Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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83365-003

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

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

83365-003-01

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83365-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83365-003-0156 g in 1 BOX; Type 0: Not a Combination Product04/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01504/21/2023
Labeler - Sichuan Gumo Brand Management Co.,Ltd (406945503)
Establishment
NameAddressID/FEIBusiness Operations
Sichuan Gumo Brand Management Co.,Ltd406945503manufacture(83365-003)

Revised: 4/2023
Document Id: f9d4e0f6-59a5-ce0f-e053-6294a90a6be5
Set id: f9d4e0f6-59a4-ce0f-e053-6294a90a6be5
Version: 1
Effective Time: 20230421
 
Sichuan Gumo Brand Management Co.,Ltd