69980-102

Drug Facts

Composition & Product

Active Ingredients

Menthol (4 g)

Inactive Ingredients

Carbomer Interpolymer Type A (55000 Cps) Linalool, (+/-)- D&c Red No. 33 Alcohol Polysorbate 20 Water Glycerin Camphor Oil Limonene, (+)- Trolamine Ethylhexylglycerin Propylene Glycol Phenoxyethanol Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Medication Information

Purpose

/

Description

Menthol 4%

Use

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Section 50566-9

Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding. have poor circulation, a skin condition or if symptoms persists.

Section 50567-7

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

Warnings

for external use only.

In cose of Ingestion seek medical assistance.

If a rash appears, dis.continue use.

Directions

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Do Not Use

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

Active Ingredient(s)

Menthol 4%

Inactive Ingredients

Water, Alcohol Denat., Polysorbate-20, Glycerin, Propylene Glycol, Triethanolamine, Phenoxyethanol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. Cinnamomum Camphora (Camphor) bark oil, Ethylhexylglycerin, limonene, Linalool, Cl42090 (FD&C Blue 1), CL17200 (D&C Red 33).

Package Label Principal Display Panel

69980-102-05 200ml

69980-102-04 150ml

69980-102-02 50ml

69980-102-01 30ml

69980-102-03 100ml

69980-102-06 30ml

69980-102-07 50ml

69980-102-08 100ml

69980-102-09 150ml

69980-102-010 200ml

69980-102-011 227ml

Structured Label Content

Use

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Section 50566-9 (50566-9)

Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding. have poor circulation, a skin condition or if symptoms persists.

Section 50567-7 (50567-7)

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

Purpose

/

Warnings

for external use only.

In cose of Ingestion seek medical assistance.

If a rash appears, dis.continue use.

Directions

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Do Not Use (Do not use)

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

Active Ingredient(s)

Menthol 4%

Inactive Ingredients (Inactive ingredients)

Water, Alcohol Denat., Polysorbate-20, Glycerin, Propylene Glycol, Triethanolamine, Phenoxyethanol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. Cinnamomum Camphora (Camphor) bark oil, Ethylhexylglycerin, limonene, Linalool, Cl42090 (FD&C Blue 1), CL17200 (D&C Red 33).

Package Label Principal Display Panel (Package Label - Principal Display Panel)

69980-102-05 200ml

69980-102-04 150ml

69980-102-02 50ml

69980-102-01 30ml

69980-102-03 100ml

69980-102-06 30ml

69980-102-07 50ml

69980-102-08 100ml

69980-102-09 150ml

69980-102-010 200ml

69980-102-011 227ml

Advanced Ingredient Data

[{"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR OIL", "unii": "75IZZ8Y727", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.", "50566-9": "Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding. have poor circulation, a skin condition or if symptoms persists.", "50567-7": "If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12", "Purpose": "/", "Warnings": "for external use only. In cose of Ingestion seek medical assistance. If a rash appears, dis.continue use.", "Directions": "Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.", "Do not use": "If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12", "Active Ingredient(s)": "Menthol 4%", "Inactive ingredients": "Water, Alcohol Denat., Polysorbate-20, Glycerin, Propylene Glycol, Triethanolamine, Phenoxyethanol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. Cinnamomum Camphora (Camphor) bark oil, Ethylhexylglycerin, limonene, Linalool, Cl42090 (FD&C Blue 1), CL17200 (D&C Red 33).", "Package Label - Principal Display Panel": "69980-102-05 200ml 69980-102-04 150ml 69980-102-02 50ml 69980-102-01 30ml 69980-102-03 100ml 69980-102-06 30ml 69980-102-07 50ml 69980-102-08 100ml 69980-102-09 150ml 69980-102-010 200ml 69980-102-011 227ml"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information