LIDOCREAM 10- lidocaine cream 
Golden Touch LLC

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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LidoCream 10

Drug Facts

Active Ingredient

Lidocaine 10% w/w

Purpose

Topical Anesthetic

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Uses For the temporary relief of pain and itching due to anorectal disorders

Warnings

For external use only

When using this product • avoid contact with eyes • do not put in rectum • do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if: • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • rectal bleeding occurs • redness, irritation, swelling, pain or other symptoms develop or increase

Directions • Adults: 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 a soft cloth before application of this product • Apply externally to the affected area upto 6 times daily • Children under 12 years of age: consult a doctor

Inactive Ingredients Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

Packaging

lido1

LIDOCREAM 10 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52763-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
ALCOHOL (UNII: 3K9958V90M)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52763-101-601 in 1 CARTON
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/05/2015
Labeler - Golden Touch LLC (194284147)
Establishment
NameAddressID/FEIBusiness Operations
Golden Touch LLC194284147manufacture(52763-101)

Revised: 11/2015
Document Id: a4e276e5-348a-4605-b829-ab0d5c20d564
Set id: 58547770-2151-4ee0-843c-b28f97b5b665
Version: 2
Effective Time: 20151111
 
Golden Touch LLC