TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER- lidocaine cream 
Dermtech Labs Inc. dba GD Labs

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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Numb & Number - Topical Anesthetic anorectal cream

Active Ingredient     Purpose
Lidocaine 5%  ..... Topical Anesthetic

Temporarily relieves local pain and discomfort of anorectal area.

Keep out of reach of Chilren

Stop use and ask your doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days.

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate-80, PPG-12/SMDI Copolyme, Propylene Glycol, Trolamine, Water

Numb & Number

Topical Anesthetic

Anorectal Cream

Net Wt 20 oz / 600g

label

TOPICAL ANESTHETIC ANORECTAL CREAM  NUMB AND NUMBER
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68848-001
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68848-001-021 in 1 PACKAGE08/11/2016
1NDC:68848-001-0154 g in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:68848-001-041 in 1 PACKAGE08/11/2016
2NDC:68848-001-03600 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/11/2016
Labeler - Dermtech Labs Inc. dba GD Labs (148077899)
Registrant - Dermtech Labs Inc. dba GD Labs (148077899)
Establishment
NameAddressID/FEIBusiness Operations
VEGE-KURL, INC021072509manufacture(68848-001)

Revised: 1/2017
Document Id: 578120ea-8e99-4f6d-9737-bf5251a10288
Set id: 1a99fa0e-a6c2-499f-81d4-79e2d052ff74
Version: 2
Effective Time: 20170103
 
Dermtech Labs Inc. dba GD Labs