SMART NUMB LIDOCAINE CREAM- lidocaine cream

SMART Numb Lidocaine Cream by

Drug Labeling and Warnings

SMART Numb Lidocaine Cream by is a Otc medication manufactured, distributed, or labeled by M.J. Winston International, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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.

ACTIVE INGREDIENT

Active Ingredients

Lidocaine 5% local anesthetic

PURPOSE

Use

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

WHEN USING

When using this product

Do not excceed recommended dosage unless directed by a doctor.

INSTRUCTIONS FOR USE

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.

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Other Information

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

QUESTIONS

Questions or concerns?

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

Use

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMART NUMB LIDOCAINE CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76092-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76092-201-02	57 g in 1 JAR; Type 0: Not a Combination Product	03/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	03/15/2024

Labeler - M.J. Winston International, Ltd. (144927378)

Establishment
Name	Address	ID/FEI	Business Operations
M.J. Winston International, Ltd.		144927378	label(76092-201)