coca lief - DailyMed Details

coca lief

SPL v1

SPL

SPL Set ID 2bedd2d0-b430-1844-e063-6294a90a965f

Route

topical

Published

Effective Date 2025-01-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

salicylic acid (12500 mg) menthol (401 mg)

Inactive Ingredients

glycerin hydroxypropylcellulose carbomer 940 erythroxylum coca leaf water methylparaben trolamine alcohol 95%

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

unapproved homeopathic active Since 2025-01-20

Purpose

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

Description

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

Medication Information

Indications and Usage

For External Use Only

Purpose

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

Dosage and Administration

aPPLY 3 TO 4 TIMES DAILY AS NEEDED

Inactive Ingredients

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

Description

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

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

Section 51945-4

Section 53414-9

If pregnant or breastfeeding consult a healthcare professional before use.

Section 60561-8

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

Active Ingredients

Menthol ........... 1.5 mg ..... Topical Analgesic

Methyl Salicylate 12.5 mg ..... Topical Analgesic

Structured Label Content

Indications and Usage (34067-9)

For External Use Only

Purpose

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

Dosage and Administration (34068-7)

aPPLY 3 TO 4 TIMES DAILY AS NEEDED

Inactive Ingredients

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding consult a healthcare professional before use.

Section 60561-8 (60561-8)

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

Active Ingredients

Menthol ........... 1.5 mg ..... Topical Analgesic

Methyl Salicylate 12.5 mg ..... Topical Analgesic

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "12500", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "401", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "HYDROXYPROPYLCELLULOSE", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "800", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "1000", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ERYTHROXYLUM COCA LEAF", "unii": "D052HE394V", "classCode": "IACT", "strengthNumerator": "500", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "60999", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "100", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "300", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1500", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ALCOHOL 95%", "unii": "7528N5H79B", "classCode": "IACT", "strengthNumerator": "21900", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For External Use Only", "34068-7": "aPPLY 3 TO 4 TIMES DAILY AS NEEDED", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50568-5": "If you are pregnant, nursing, or have a medical condition consult a healthcare professional before use.", "53414-9": "If pregnant or breastfeeding consult a healthcare professional before use.", "60561-8": "Store at 66 to 92 degress Farenheit. Do not leave in direct sunlight.", "Purpose": "Temporary relief of aches and pains associated with <Arthritis, Carpal Tunnel, Swelling, Sprains, Brusing and Inflamation", "Active Ingredients": "Menthol ........... 1.5 mg ..... Topical Analgesic Methyl Salicylate 12.5 mg ..... Topical Analgesic", "Inactive Ingredients": "Trolamine, 95% Isopropyl Alcohol, cellulose, Gycerine, Coca-leaf extract."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:55.825813 · Updated: 2026-03-14T23:17:14.395389