LIDOCAINE PLANTAR FASCIITIS HEEL PAIN RELIEF CREAM- 4% lidocaine, 1% menthol cream

LIDOCAINE PLANTAR FASCIITIS Heel Pain Relief Cream by

Drug Labeling and Warnings

LIDOCAINE PLANTAR FASCIITIS Heel Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Guangzhou Zhupuyou E-commerce Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIDOCAINE PLANTAR FASCIITIS Heel Pain Relief Cream

ACTIVE INGREDIENT

4% LIDOCAINE, 1% Menthol

PURPOSE

PURPOSE

Topical anesthetic

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 swalkowed 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 indoors in a cool and shady place

INACTIVE INGREDIENT

Water
Paraffinum Liquidum
Glycerin
Cetearyl Alcohol
Glyceryl Stearate
Polysorbate 60
Peg-100 Stearate
Polyacrylamide
Phenoxyethanol
Allantoin
Carbomer
Phryma Leptostachya Extract
Zingiber Officinale (Ginger) Root Extract
Angelica Sinensis Extract
Panax Ginseng Extract
Ligusticum Chuanxiong Extract
Triethanolamine
Methylparaben
C13-14 Isoparaffin
Laureth-7
Disodium Edta

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PLANTAR FASCIITIS HEEL PAIN RELIEF CREAM 
4% lidocaine, 1% menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
LIGUSTRAZINE (UNII: V80F4IA5XG)
GINGER (UNII: C5529G5JPQ)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEG-100 STEARATE (UNII: YD01N1999R)
LAURETH-7 CARBOXYLIC ACID (UNII: 3180MRU2VG)
CETYL ACETATE (UNII: 4Q43814HXS)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
ALLANTOIN (UNII: 344S277G0Z)
PANAXYNOL (UNII: 8P1DJD416I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-101-01	60 g in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2024
2	NDC: 84165-101-02	114 g in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/08/2024

Labeler - Guangzhou Zhupuyou E-commerce Co., Ltd (418214143)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Zhupuyou E-commerce Co., Ltd		418214143	manufacture(84165-101)