84165-015 Plantar Relief Roll-on

84165-015 Plantar Relief Roll-on
SPL v2
SPL
SPL Set ID 3c9ee60b-548a-979f-e063-6394a90a70b0
Route
TOPICAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Carbomer Aloe Vera Leaf Phenoxyethanol Lavender Oil Tartaric Acid Isopropyl Myristate Polysorbate 80 Propylene Glycol Water .alpha.-tocopherol, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-18

Description

Lidocaine 4% Menthol 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,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 adoctor

Description

Lidocaine 4% Menthol 1%

Section 50565-1

If swallowed accidentally,get medicalhelp or contact with Poison ControlCenter immediately

Section 50566-9



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

condition worsens or symptoms persist for more than7 days

symptoms clear up and occur again within a few days

redness is present or excessive skin irritation occurs

Section 50567-7



use only as directed

avoid contact with the eyes, mucous membranes, 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 this product

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 Anesthetic

Topical Analgesic

Section 55106-9

Lidocaine 4%

Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,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 adoctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed accidentally,get medicalhelp or contact with Poison ControlCenter immediately

Section 50566-9 (50566-9)



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

condition worsens or symptoms persist for more than7 days

symptoms clear up and occur again within a few days

redness is present or excessive skin irritation occurs

Section 50567-7 (50567-7)



use only as directed

avoid contact with the eyes, mucous membranes, 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 this product

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 Anesthetic

Topical Analgesic

Section 55106-9 (55106-9)

Lidocaine 4%

Menthol 1%


Advanced Ingredient Data


Raw Label Data

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