lidozen patch

lidozen patch
SPL v3
SPL
SPL Set ID d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6
Route
topical
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (40 mg) menthol (10 mg)
Inactive Ingredients
water glycerin propylene glycol polysorbate 80 tartaric acid dihydroxyaluminum aminoacetate methylparaben

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-01

Description

Lidocaine 4.00% Menthol 1.00%


Medication Information

Inactive Ingredients

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

Description

Lidocaine 4.00% Menthol 1.00%

Uses:

For temporary relief of pain

Section 42229-5

Store below 25 degrees Celsius. Avoid direct sunlight.

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 4.00%

Menthol 1.00%

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):

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8-hours.

Do not use patches for longer than five consecutive days.

Children under 12 should consult physician prior to use.


Structured Label Content

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

Uses: (USES:)

For temporary relief of pain

Section 42229-5 (42229-5)

Store below 25 degrees Celsius. Avoid direct sunlight.

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 4.00%

Menthol 1.00%

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):)

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8-hours.

Do not use patches for longer than five consecutive days.

Children under 12 should consult physician prior to use.


Advanced Ingredient Data


Raw Label Data

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