SMART NUMB LIDOCAINE CREAM- lidocaine cream 
M.J. Winston International, Ltd.

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WARNINGS

For external use only.

Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.

WARNINGS

Active Ingredients

Lidocaine 5% local anesthetic

active

Use

For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation.

use

When using this product

Do not excceed recommended dosage unless directed by a doctor.

when using this product

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. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.

directions

Inactive Ingredients

Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6

inactive

Other Information

Store at 59F to 86F (15C to 30C). Keep away from direct sunlight.

other info

Questions or concerns?

Contact info@smartmed.us or 714-582-2715.

questions

Keep out of reach of children.

keep out of reach of children

dosage administration

Use

For the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation.

indication

package label principal

SMART NUMB LIDOCAINE CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76092-201
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
MENTHOL (UNII: L7T10EIP3A)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)  
WATER (UNII: 059QF0KO0R)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EMU OIL (UNII: 344821WD61)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76092-201-0257 g in 1 JAR; Type 0: Not a Combination Product03/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01503/15/2024
Labeler - M.J. Winston International, Ltd. (144927378)
Establishment
NameAddressID/FEIBusiness Operations
M.J. Winston International, Ltd.144927378label(76092-201)

Revised: 2/2024
Document Id: 1138c88a-447d-644e-e063-6294a90aab3f
Set id: 1138c88a-447c-644e-e063-6294a90aab3f
Version: 1
Effective Time: 20240212
 
M.J. Winston International, Ltd.