SPL v2
SPL
SPL Set ID 2ea9d34e-408d-f8d6-e063-6394a90a72a4
Route
TOPICAL
Published
Effective Date 2025-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Squalane Rice Germ Prilocaine Simmondsia Chinensis (jojoba) Seed Oil Menthol Aloe Barbadensis Leaf Procaine Glyceryl Stearate Xanthan Gum Dimethicone Glycerin Sheanut Oil Cetearyl Glucoside Mentha Arvensis Leaf Butylene Glycol Centella Asiatica Root Sodium Hyaluronate Tocopherol Tetracaine Cetearyl Alcohol Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20
Description

Lidocaine 4% - Local anesthetic for 8 hours

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Lidocaine 4% - Local anesthetic for 8 hours

Attention
  • Do not get into eyes.
  • Do not swallow.
  • Do not exceed the recommended dosage unless directed by a doctor.
  • Do not insert this product into the recturm.
Important

Keep out of reach of children.

Do Not Use
  • If you are pregnant or nursing, consult with your healthcare provider before use.
  • The product seal is broken or missing.
  • Do not use on broken or irritated skin.
  • People who are allergic to the ingredients in this product.
Active Ingredient

Lidocaine 4% - Local anesthetic for 8 hours

Other Ingredients

Water, Glycerin, Butyllene Glycol, Butter Oil, Squalane, Dimethicone, Menthol, Borneol, Xanthan Gum.

Dosage & Administration
  • Due to the different in temprature and skin type, the duration of the numbness effect will be different.
  • First test in a small area is recommended to ensure the best numbness effect.
Principal Display Panel

Useage Before Tattooing

1. Clean hands and treatment are with mild soap and warm water. Rinse thoroughly and gently pat dry.

2. Apply a thick numbing cream to the treatment area, making sure to cover the tattoo and its surroundings.

3. Wrap tightly with plastic wrap and wait for 40-60 munutes.

4. Wipe away any exceess residue and allow addtional 15-25 minutes for the numbing effect to reach its peak. Then you can begin the tattoo procedure.

Structured Label Content

Purpose (PURPOSE)

External Analgesic

Attention (ATTENTION)
  • Do not get into eyes.
  • Do not swallow.
  • Do not exceed the recommended dosage unless directed by a doctor.
  • Do not insert this product into the recturm.
Important (IMPORTANT)

Keep out of reach of children.

Do Not Use (DO NOT USE)
  • If you are pregnant or nursing, consult with your healthcare provider before use.
  • The product seal is broken or missing.
  • Do not use on broken or irritated skin.
  • People who are allergic to the ingredients in this product.
Active Ingredient (ACTIVE INGREDIENT)

Lidocaine 4% - Local anesthetic for 8 hours

Other Ingredients (OTHER INGREDIENTS)

Water, Glycerin, Butyllene Glycol, Butter Oil, Squalane, Dimethicone, Menthol, Borneol, Xanthan Gum.

Dosage & Administration (DOSAGE & ADMINISTRATION)
  • Due to the different in temprature and skin type, the duration of the numbness effect will be different.
  • First test in a small area is recommended to ensure the best numbness effect.
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Useage Before Tattooing (USEAGE BEFORE TATTOOING)

1. Clean hands and treatment are with mild soap and warm water. Rinse thoroughly and gently pat dry.

2. Apply a thick numbing cream to the treatment area, making sure to cover the tattoo and its surroundings.

3. Wrap tightly with plastic wrap and wait for 40-60 munutes.

4. Wipe away any exceess residue and allow addtional 15-25 minutes for the numbing effect to reach its peak. Then you can begin the tattoo procedure.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:38.158370 · Updated: 2026-03-14T23:07:45.169331