Active Ingredients And Purpose
Active Ingredients
Lidocaine 4% Menthol 1%
Uses
temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites
Lidocaine 4% Plus Menthol 1% Pain Relief Cream
- Manufacturer
- MOHNARK PHARMACEUTICALS INC
- Effective date
- 2025-08-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:10:48
Key Label Information
Uses
Uses
temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites
Usage
Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.
Warnings
Warnings
For external use only.
Stop use and ask a doctor if
• allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • redness, irritation, swelling, pain or other symptoms begin or increase
Directions And Dosage
Directions
• Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day. • Children under 2 years of age: consult a doctor.
Dosage and Administration
Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age. Consult a doctor.
Other Label Information
Other information
• Store at USP controlled room temperature 20-25°C (68-77°F).
Inactive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.
Package Label
Products
- Lidocaine 4% plus Menthol 1% Topical Anesthetic Pain Cream
- Lidocaine 4% plus Menthol 1% Pain Cream
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
Complete SPL Sections
Active Ingredients
Lidocaine 4% Menthol 1%
Uses
temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites
Warnings
For external use only.
When using this product
• do not use in or near the eyes • do not use in large quantities, particularly over raw surfaces or blistered area
Stop use and ask a doctor if
• allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • redness, irritation, swelling, pain or other symptoms begin or increase
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day. • Children under 2 years of age: consult a doctor.
Other information
• Store at USP controlled room temperature 20-25°C (68-77°F).
Inactive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.
Usage
Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.
Dosage and Administration
Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age. Consult a doctor.
Package Label
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/3c723fdf-cb6d-53b0-e063-6294a90a1339/3c723fdf-cb6e-53b0-e063-6294a90a1339.xml
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- dd566a78684a46f39ef8f5d889f7b71e71a28a767102c0431a0466edd5805384
- XML bytes
- 16597
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 3c723fdf-cb6e-53b0-e063-6294a90a1339.xml | 2025-08-19 |
| otc | fda_panel.jpg | 2025-08-19 |