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

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

Section 55106-9

Lidocaine 4%

Menthol 1%


Structured Label Content

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

Warnings and Precautions (34071-1)

For external use only

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

Section 55106-9 (55106-9)

Lidocaine 4%

Menthol 1%


Advanced Ingredient Data


Raw Label Data

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