Lidozen Patch

Lidozen Patch
SPL v6
SPL
SPL Set ID 488d665c-a4fe-4a69-bab3-34b2347f4b05
Route
TOPICAL
Published
Effective Date 2023-12-01
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 2019-09-16

Description

Lidocaine 4.00% Menthol 1.00%


Medication Information

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%

Inactive Ingredients:

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

Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding, 

ask a health professional before use.

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

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%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

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.
If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.

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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