84165-003 lidocaine pain relief gel roll-on

84165-003 lidocaine pain relief gel roll-on
SPL v3
SPL
SPL Set ID 31639407-0f11-bde2-e063-6294a90af694
Route
topical
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.01 g) lidocaine (0.04 g)
Inactive Ingredients
aloe vera leaf lavender oil polysorbate 80 tartaric acid water carbomer propylene glycol .alpha.-tocopherol, d- phenoxyethanol isopropyl myristate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-28

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 minorjoin pains 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 waterafter each use

children under 12 years of age: ask a doctor

Description

Lidocaine 4% Menthol 1%

Section 50565-1

lf swallowed accidentally ,get medical help orcontact 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, 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, orliniments

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


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 minorjoin pains 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 waterafter each use

children under 12 years of age: ask a doctor

Section 50565-1 (50565-1)

lf swallowed accidentally ,get medical help orcontact 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, 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, orliniments

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


Advanced Ingredient Data


Raw Label Data

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