Lidozen Gel

Lidozen Gel
SPL v3
SPL
SPL Set ID ffb7831f-4ca9-4d73-8303-e9cd90078982
Route
TOPICAL
Published
Effective Date 2026-01-01
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 Whole Indian Frankincense Green Tea Leaf Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Glycerin Isopropyl Myristate Polyethylene Glycol 400 Phenoxyethanol Polysorbate 80 Sodium Lauryl Sulfate Trolamine Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-01
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.
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, Polysorate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

If Pregnant Or Breast Feeding,
  • •
    ask a health professional before use.
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  (Do not use )
  • •
    in large quantities, particularly over raw surfaces or blistered areas.
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, Polysorate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
  • •
    ask a health professional before use.
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: 2026-02-15T12:08:19.399502 · Updated: 2026-03-14T23:12:31.383435