LIDOCAINE PAIN RELIEF CREAM- 4% lidocaine cream

Lidocaine Pain Relief Cream by

Drug Labeling and Warnings

Lidocaine Pain Relief 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

Lidocaine Pain Relief Cream

ACTIVE INGREDIENT

LIDOCAINE 4%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

WARNINGS

For external use only

DO NOT USE

On wounds or damaged skin
With a heating pad or device
With other ointments, creams, sprays, or liniments
If you are allergic to any ingredients of this product

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
symptoms persist for more than 7 days

KEEP OUT OF REACH OF CHILDREN

If swallowed accidentally , get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Children under 12: Consult a doctor.
Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting withl toilet tissue or a clean, soft cloth before application of this product.

STORAGE AND HANDLING

Store in a dry and cool place

PREGNANCY OR BREAST FEEDING

ask a health professional before use.

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

LIDOCAINE PAIN RELIEF CREAM 
4% lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84019-101
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
PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
PORTULACA OLERACEA SEED (UNII: M08917G08Z)
TETRACAINE (UNII: 0619F35CGV)
EPINEPHRINE (UNII: YKH834O4BH)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PRILOCAINE (UNII: 046O35D44R)
BORNEOL (UNII: M89NIB437X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84019-101-01	1 in 1 BOX	01/24/2024
1		30 g in 1 CANISTER; Type 0: Not a Combination Product
2	NDC: 84019-101-02	1 in 1 BOX	01/24/2024
2		50 g in 1 CANISTER; Type 0: Not a Combination Product
3	NDC: 84019-101-03	1 in 1 BOX	01/24/2024
3		142 g in 1 CANISTER; Type 0: Not a Combination Product
4	NDC: 84019-101-04	1 in 1 BOX	01/24/2024
4		156 g in 1 CANISTER; Type 0: Not a Combination Product
5	NDC: 84019-101-05	1 in 1 BOX	01/24/2024
5		170 g in 1 CANISTER; Type 0: Not a Combination Product
6	NDC: 84019-101-06	1 in 1 BOX	01/24/2024
6		184 g in 1 CANISTER; Type 0: Not a Combination Product
7	NDC: 84019-101-07	1 in 1 BOX	01/24/2024
7		198 g in 1 CANISTER; Type 0: Not a Combination Product
8	NDC: 84019-101-08	1 in 1 BOX	01/24/2024
8		213 g in 1 CANISTER; Type 0: Not a Combination Product
9	NDC: 84019-101-09	1 in 1 BOX	01/24/2024
9		227 g in 1 CANISTER; Type 0: Not a Combination Product
10	NDC: 84019-101-10	1 in 1 BOX	01/24/2024
10		241 g in 1 CANISTER; 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	01/24/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Shengnan (Guangzhou) Cosmetics Co., LTD		541200425	manufacture(84019-101)