Lidozen Gel

Lidozen Gel
SPL v3
SPL
SPL Set ID 55108ffd-d6a8-41de-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Indian Frankincense Green Tea Leaf Carboxypolymethylene Ethylhexylglycerin Glycerin Trolamine Fd&c Blue No. 1 Fd&c Yellow No. 5 Isopropyl Myristate Polyethylene Glycol 400 Phenoxyethanol Polysorbate 80 Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-22
Description

Lidocaine HCL 4.00% Menthol 1.00%

Medication Information

Description

Lidocaine HCL 4.00% Menthol 1.00%

Uses:

For temporary relief of pain

Section 55105-1

Topical Anesthetic

External Analgesic

Warnings:
  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • ​ ask a health professional before use. ​If pregnant or breast-feeding,
Package Labeling:

Active Ingredients:

Lidocaine HCL 4.00%

Menthol 1.00%

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Directions (adults and Children Over 12 Years):

Apply directly to affected area. Do not use more than four times per day.

Structured Label Content

Uses: (USES:)

For temporary relief of pain

Section 55105-1 (55105-1)

Topical Anesthetic

External Analgesic

Warnings: (WARNINGS:)
  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • ​ ask a health professional before use. ​If pregnant or breast-feeding,
Package Labeling:

Active Ingredients: (ACTIVE INGREDIENTS:)

Lidocaine HCL 4.00%

Menthol 1.00%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, get medical help or contact a Poison Control Center right away.
Directions (adults and Children Over 12 Years): (DIRECTIONS (Adults and Children Over 12 Years):)

Apply directly to affected area. Do not use more than four times per day.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.923495 · Updated: 2026-03-14T23:01:48.065872