SIMPLY NUMB ENDURE- 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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Simply Numb Endure

Active ingredient

Lidocaine 5% 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

Warnings

For external use only

When using this product


Stop use and ask a doctor if

Directions

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

Simply Numb

SIMPLY NUMB ENDURE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52763-600
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
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:52763-600-3030 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:52763-600-6060 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:52763-600-055 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/08/2014
Labeler - Golden Touch LLC (194284147)
Establishment
NameAddressID/FEIBusiness Operations
Golden Touch LLC194284147manufacture(52763-600)

Revised: 11/2015
Document Id: c611f727-311d-4629-92ea-c40f2d805de3
Set id: 30b1c8db-1b38-4c04-9a3a-8415369a847c
Version: 2
Effective Time: 20151112
 
Golden Touch LLC