Theraice Tm

Theraice Tm
SPL v2
SPL
SPL Set ID fe0478d8-2f06-cd56-e053-6294a90a58e5
Route
TOPICAL
Published
Effective Date 2023-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.12 g) Lidocaine (0.48 g)
Inactive Ingredients
Kaolin Tartaric Acid Water Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Mineral Oil Polysorbate 80 Glycerin Edetate Disodium Povidone K90 Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-15
Description

Lidocaine 4% w/w ...... Purpose: Topical Anesthetic Menthol 1% w/w ...... Purpose: Topical Analgesic

Purpose

Topical Anesthetic (Lidocaine) Topical Analgesic (Menthol)

Medication Information

Purpose

Topical Anesthetic (Lidocaine)

Topical Analgesic (Menthol)

Description

Lidocaine 4% w/w ...... Purpose: Topical Anesthetic Menthol 1% w/w ...... Purpose: Topical Analgesic

Use

for temporary relief of pain

Warnings

For External Use Only

Directions

Adults and Children 12 years of age and over.

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from the skin after 8-hour application at most

Children under 12 years of age: Consult a physician

Do Not Use
  • More than 1 patch at a time
  • If you are allergic to any ingredients of this product
  • On wounds or damaged skin
  • In large quantities, particularly over raw surfaces or blistered areas
Other Information
  • Store at 68° - 77° F (20° - 25° C)
  • Store in a cool dry place away from direct sunlight
Active Ingredients

Lidocaine 4% w/w ...... Purpose: Topical Anesthetic

Menthol 1% w/w ...... Purpose: Topical Analgesic

Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
If Pregnant Or Breast Feeding

ask a physician before use.

Keep Out of Reach of Children.

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

Stop Use and Consult A Doctor If
  • Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms clear up and occur again within a few days
  • Symptoms persist for more than 7 days
Package Label. Principal Display Panel

Structured Label Content

Use

for temporary relief of pain

Purpose

Topical Anesthetic (Lidocaine)

Topical Analgesic (Menthol)

Warnings

For External Use Only

Directions

Adults and Children 12 years of age and over.

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from the skin after 8-hour application at most

Children under 12 years of age: Consult a physician

Do Not Use (Do not use)
  • More than 1 patch at a time
  • If you are allergic to any ingredients of this product
  • On wounds or damaged skin
  • In large quantities, particularly over raw surfaces or blistered areas
Other Information
  • Store at 68° - 77° F (20° - 25° C)
  • Store in a cool dry place away from direct sunlight
Active Ingredients

Lidocaine 4% w/w ...... Purpose: Topical Anesthetic

Menthol 1% w/w ...... Purpose: Topical Analgesic

Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a physician 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.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms clear up and occur again within a few days
  • Symptoms persist for more than 7 days
Package Label. Principal Display Panel (Package label. Principal display panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:07.935290 · Updated: 2026-03-14T23:04:37.184149