3c08eccb-e923-44c6-b514-38f3eca81eb2

SPL v1
SPL
SPL Set ID 3c08eccb-e923-44c6-b514-38f3eca81eb2
Route
topical
Published
Effective Date 2021-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
water arnica montana flower c13-14 isoparaffin sodium chondroitin sulfate (porcine; 5500 mw) emu oil diethylene glycol monoethyl ether ethylhexylglycerin glucosamine sulfate isopropyl palmitate laureth-7 melaleuca alternifolia leaf dimethyl sulfone phenoxyethanol polyacrylamide (10000 mw) propylene glycol stearic acid trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-09-16

Purpose

External Analgesic

Description

Lidocaine 4% w/w


Medication Information

Warnings

For external use only.

Avoid contact with eyes.

Do not use in large quantities, particularly over the raw surfaces or blistered area 

Stop use and ask a doctor if

condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

Uses

For temporary relief of pain and itching due to minor skin irritations.

Purpose

External Analgesic

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Description

Lidocaine 4% w/w

Drug Facts

Product Label

Active Ingredient

Lidocaine 4% w/w

Questions Or Comments?
Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Warnings (warnings)

For external use only.

Avoid contact with eyes.

Do not use in large quantities, particularly over the raw surfaces or blistered area 

Stop use and ask a doctor if

condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

Uses

For temporary relief of pain and itching due to minor skin irritations.

Purpose

External Analgesic

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine 4% w/w

Questions Or Comments? (Questions or comments?)
Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)