NUMB SKIN - lidocaine cream cream 
Seenext Venture 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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Drug Facts

Active Ingredient

Lidocaine 5%

Purpose

Anorectal (Hemmorhoidal)

Uses

For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders.

Warnings

For external use only

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop the use and consult doctor if:

  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • condition worsenss or does not improve within 7 days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingrdients

Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Water

Question or comments

Call weekdays 9 AM to 6 PM PST at 1-844-700-6862 or email us at support@numbskin.com

Principal Display Panel

NDC 70907-001-15

FOR EXTERNAL USE ONLY

NumbSkin Cream ®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 15g

Label

NDC 70907-001-30

FOR EXTERNAL USE ONLY

NumbSkin Cream ®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 30g

Label 1

NUMB SKIN  
lidocaine cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70907-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
PROPYLENE GLYCOL BUTYL ETHER (UNII: 6X8776AP5Z)  
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70907-001-301 in 1 CARTRIDGE09/01/2016
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70907-001-151 in 1 CARTRIDGE04/29/2020
215 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/01/2016
Labeler - Seenext Venture Ltd (203416862)
Registrant - Seenext Venture Ltd (203416862)

Revised: 11/2022
Document Id: ed0f3275-f159-13a3-e053-2a95a90a2ce8
Set id: 3ac18167-774b-3777-e054-00144ff8d46c
Version: 8
Effective Time: 20221109
 
Seenext Venture Ltd