COCA LIEF- menthol, methylsalicylate gel

COCA LIEF by

Drug Labeling and Warnings

COCA LIEF by is a Homeopathic medication manufactured, distributed, or labeled by INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol ........... 1.5 mg ..... Topical Analgesic
Methyl Salicylate 12.5 mg ..... Topical Analgesic

Purpose

Temporary relief of aches and pains associated with <Arthritis, Carpal Tunnel, Swelling, Sprains, Brusing and Inflamation

WARNINGS

If you are pregnant, nursing, or have a medical condition consult a healthcare professional before use.

For External Use Only

If pregnant or breastfeeding consult a healthcare professional before use.

Keep out of reach of children.

STOP USE

Stop use and consult a doctor if condition worsens or if sympotoms last for more than 7 days, or if condition clears up but occurs again a few days later, or if you dicsover a rash/irritation.

OTHER SAFETY INFORMATION

Store at 66 to 92 degress Farenheit. Do not leave in direct sunlight.

aPPLY 3 TO 4 TIMES DAILY AS NEEDED

Inactive Ingredients

Trolamine, 95% Isopropyl Alcohol, cellulose, Gycerine, Coca-leaf extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COCA LIEF 
menthol, methylsalicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84831-096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	12500 mg  in 100000 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1500 mg  in 100000 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	401 mg  in 100000 mg
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)	800 mg  in 100000 mg
CARBOMER 940 (UNII: 4Q93RCW27E)	1000 mg  in 100000 mg
ERYTHROXYLUM COCA LEAF (UNII: D052HE394V)	500 mg  in 100000 mg
WATER (UNII: 059QF0KO0R)	60999 mg  in 100000 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	100 mg  in 100000 mg
TROLAMINE (UNII: 9O3K93S3TK)	300 mg  in 100000 mg
ALCOHOL 95% (UNII: 7528N5H79B)	21900 mg  in 100000 mg

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84831-096-01	100000 mg in 1 TUBE; Type 0: Not a Combination Product	01/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/20/2025

Labeler - INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L. (815366311)

Establishment
Name	Address	ID/FEI	Business Operations
INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.		815366311	manufacture(84831-096)