Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 91b0d5d6-bfa1-2b78-e053-2995a90aacf7
Route
TOPICAL
Published
Effective Date 2019-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-08-31

Description

lidocaine, menthol


Medication Information

Warnings and Precautions

- Warnings

For external use only.

Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients.

- Do not Use

More than 1 patch on your body at a time or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Indications and Usage

Use only as directed. Read and follow all directions and warnings on this label.

Do not allow contact with the eyes and mucous membranes

Do not bandage tightly or apply local heat (such as heating pads) to the area of use

Do not use at the same time as other topical analgesics

Dispose of used patch in manner that always keeps product away from children and pets

Used patch still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests patch

Dosage and Administration

for external use only

Description

lidocaine, menthol

Section 50565-1

keep out of reach of the children

Section 51727-6

Methylparaben, Propylparaben, Sodium Polyacrylate, Polyacrylic Acid 20% Solution, Gelatin, Carboxymethyl Cellulose, Titanium Oxide, Kaolin, Dihydroxyaluminium Aminoacetate, Concentrated Glycerin, D-Sorbitol Solution, Urea, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Tartaric Acid, Propylene Glycol, Purified Water

Section 51945-4

Section 55105-1

Temporary relief of minor pain

Section 55106-9

lidocaine, menthol


Structured Label Content

Indications and Usage (34067-9)

Use only as directed. Read and follow all directions and warnings on this label.

Do not allow contact with the eyes and mucous membranes

Do not bandage tightly or apply local heat (such as heating pads) to the area of use

Do not use at the same time as other topical analgesics

Dispose of used patch in manner that always keeps product away from children and pets

Used patch still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests patch

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

- Warnings

For external use only.

Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients.

- Do not Use

More than 1 patch on your body at a time or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Methylparaben, Propylparaben, Sodium Polyacrylate, Polyacrylic Acid 20% Solution, Gelatin, Carboxymethyl Cellulose, Titanium Oxide, Kaolin, Dihydroxyaluminium Aminoacetate, Concentrated Glycerin, D-Sorbitol Solution, Urea, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Tartaric Acid, Propylene Glycol, Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporary relief of minor pain

Section 55106-9 (55106-9)

lidocaine, menthol


Advanced Ingredient Data


Raw Label Data

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