LIDOCAINE- lidocaine cream 
CHENGDU DISCOUNT TRADING 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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001

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 )

Do not use

Do not use this product if

pregnant or breastfeeding , ask a health professional before use.

in case of accidental overdose , get medical help or contact the Poison Control Center immediately.

tamper evident " Do not use this product " if seal is broken or missing.

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

82927-001-01

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82927-001
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
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:82927-001-0156 g in 1 BOX; Type 0: Not a Combination Product08/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01508/08/2022
Labeler - CHENGDU DISCOUNT TRADING CO.LTD (705325854)
Establishment
NameAddressID/FEIBusiness Operations
CHENGDU DISCOUNT TRADING CO.LTD705325854manufacture(82927-001)

Revised: 7/2022
Document Id: e32f1a47-9a5c-73de-e053-2995a90a28a4
Set id: e32f1a47-9a5b-73de-e053-2995a90a28a4
Version: 1
Effective Time: 20220706
 
CHENGDU DISCOUNT TRADING CO.LTD