NUMB CREAM- lidocaine cream

Numb Cream by

Drug Labeling and Warnings

Numb Cream by is a Otc medication manufactured, distributed, or labeled by Shengnan (Guangzhou) Cosmetics Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Numb Cream

ACTIVE INGREDIENT

LIDOCAINE 4%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For temporarily relieve local discomfort, itching, pain, soreness or burning sensation on hands, legs, back and other skin.

WARNINGS

For external use only

DO NOT USE

lf pregnant or breast-feeding, ask a health professional before use.

WHEN USING

Use only as directed.
Avoid contact with the eyes,
mucous membranes, or rashes.
Do not bandage tightly.

STOP USE

skin reactions such as redness.swelling, blistering or other discomfort occur.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.
lf swallowed accidentally, get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION

1.For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly.
2.Apply externally to the affected area up to 6 times.

INACTIVE INGREDIENT

Water
Propylene Glycol
Carbomer
Glycerin
Disodium Edta
Hydroxyacetophenone
1.2-Hexanediol
Mentha Arvensis Leaf Extract
Chrysanthellum Indicum Extract
Portulaca Oleracea Extract
Peg-40 Hydrogenated Castor Oil
Epinephrine
Tetracaine
Prilocaine
Borneol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUMB CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84019-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
PORTULACA OLERACEA SEED (UNII: M08917G08Z)
WATER (UNII: 059QF0KO0R)
PRILOCAINE (UNII: 046O35D44R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TETRACAINE (UNII: 0619F35CGV)
EPINEPHRINE (UNII: YKH834O4BH)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
BORNEOL (UNII: M89NIB437X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84019-301-01	1 in 1 BOX	02/22/2024
1		10 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84019-301-02	1 in 1 BOX	02/22/2024
2		30 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 84019-301-03	1 in 1 BOX	02/22/2024
3		50 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 84019-301-04	1 in 1 BOX	02/22/2024
4		60 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 84019-301-05	1 in 1 BOX	02/22/2024
5		100 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 84019-301-06	1 in 1 BOX	02/22/2024
6		120 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 84019-301-07	1 in 1 BOX	02/22/2024
7		150 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 84019-301-08	1 in 1 BOX	02/22/2024
8		200 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 84019-301-09	1 in 1 BOX	02/22/2024
9		250 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 84019-301-10	1 in 1 BOX	02/22/2024
10		300 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC: 84019-301-11	1 in 1 BOX	02/22/2024
11		500 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/22/2024

Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)

Establishment
Name	Address	ID/FEI	Business Operations
Shengnan (Guangzhou) Cosmetics Co., LTD		541200425	manufacture(84019-301)