84165-017 foot pain relief roll-on

84165-017 foot pain relief roll-on
SPL v1
SPL
SPL Set ID 43edcea0-ab04-f368-e063-6294a90a817a
Route
topical
Published
Effective Date 2025-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g) menthol (1 g)
Inactive Ingredients
.alpha.-tocopherol, d- lavender oil phenoxyethanol carbomer tartaric acid aloe vera leaf isopropyl myristate polysorbate 80 propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-19

Description

Lidocaine 4% Menthol 1%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Lidocaine 4%

Menthol 1%

Indications and Usage

Temporarily relieves muscle soreness and minorjoint pains in the wrist, knees, back, neck, hipsshoulders,elbows.

Dosage and Administration



Adults and Children above 12 years old:

apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

massage until thoroughly absorbed into skin

wash hands thoroughly with soap and water after each use

children under 12 years of age: ask a doctor

Description

Lidocaine 4% Menthol 1%

Section 50565-1

If swallowed accidentally , get medical help or contact with Poison Control Center immediately.

Section 50566-9



skin reactions such as redness, swelling,blistering or other discomfort occur

condition worsens or symptoms persist formore than 7 days

symptoms clear up and occur again within afew days

redness is present or excessive skin irritation occurs

Section 50567-7



use only as directed

avoid contact with the eyes, mucousmembranes, or rashes

do not bandage tightly

do not expose the area to local heat or to direct sunlight

Section 50570-1

on wounds or on irritated or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if your are allergic to any ingredients of thisproduct

Section 51727-6

.ALPHA.-TOCOPHEROL, D-

Aloe Vera Extract

Carbomer

Isopropyl myristate

Lavender Oil

Phenoxyethanol

Polysorbate 80

Propylene Glycol

Tartaric acid

Water

Section 51945-4

Section 55105-1

Topical Analgesic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Lidocaine 4%

Menthol 1%

Indications and Usage (34067-9)

Temporarily relieves muscle soreness and minorjoint pains in the wrist, knees, back, neck, hipsshoulders,elbows.

Dosage and Administration (34068-7)



Adults and Children above 12 years old:

apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

massage until thoroughly absorbed into skin

wash hands thoroughly with soap and water after each use

children under 12 years of age: ask a doctor

Section 50565-1 (50565-1)

If swallowed accidentally , get medical help or contact with Poison Control Center immediately.

Section 50566-9 (50566-9)



skin reactions such as redness, swelling,blistering or other discomfort occur

condition worsens or symptoms persist formore than 7 days

symptoms clear up and occur again within afew days

redness is present or excessive skin irritation occurs

Section 50567-7 (50567-7)



use only as directed

avoid contact with the eyes, mucousmembranes, or rashes

do not bandage tightly

do not expose the area to local heat or to direct sunlight

Section 50570-1 (50570-1)

on wounds or on irritated or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if your are allergic to any ingredients of thisproduct

Section 51727-6 (51727-6)

.ALPHA.-TOCOPHEROL, D-

Aloe Vera Extract

Carbomer

Isopropyl myristate

Lavender Oil

Phenoxyethanol

Polysorbate 80

Propylene Glycol

Tartaric acid

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)