efd3289f-dfb2-487c-a76f-00fe8af414e3

SPL v3
SPL
SPL Set ID efd3289f-dfb2-487c-a76f-00fe8af414e3
Route
topical
Published
Effective Date 2024-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
water alcohol aloe vera leaf dimethyl sulfone propylene glycol diethylene glycol monoethyl ether arnica montana flower glycerin phenoxyethanol edetate disodium ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-09

Purpose

External Analgesic

Description

Lidocaine HCL 4.0% 


Medication Information

Warnings

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Keep away from face to avoid breathing it. Avoid contact with eyes. Do not store at temperatures above 120°F. Do not puncture or incinerate.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of childrenand pets If swallowed get medical help or contact a Poison Control Center right away.

Uses

For temporary relief of pain and itching.

Purpose

External Analgesic

Directions

Shake well. Do not spray on face. Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily. Children 12 years of age or younger: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Aqua (Deionized Water), Dimethyl Sulfone, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, SD Alcohol 40-B

Description

Lidocaine HCL 4.0% 

Section 50565-1

Drug Facts

Product Label

Active Ingredient

Lidocaine HCL 4.0% 


Structured Label Content

Warnings

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Keep away from face to avoid breathing it. Avoid contact with eyes. Do not store at temperatures above 120°F. Do not puncture or incinerate.

Stop use and ask doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of childrenand pets If swallowed get medical help or contact a Poison Control Center right away.

Uses

For temporary relief of pain and itching.

Purpose

External Analgesic

Directions

Shake well. Do not spray on face. Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily. Children 12 years of age or younger: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Aqua (Deionized Water), Dimethyl Sulfone, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, SD Alcohol 40-B

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine HCL 4.0% 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)