83804-113

83804-113
SPL v1
SPL
SPL Set ID 3d7e6757-f183-2a68-e063-6294a90ae4ca
Route
TOPICAL
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Propylene Glycol Aloe Vera Whole Hydrogenated Soybean Lecithin Carbomer Water .alpha.-tocopherol Acetate Triethanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-29

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Use

For the temporary relief of pain, burning and soreness.

Stop Use

If Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use.

●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.

Warnings

Warnings (For external use only)

●Do not bandage tightly; do not use with heating pad; do not apply to large areas or on broken/irritated skin.

●Do not this product if pregnant or breastfeeding, ask a health professional before use.

●Do not use on large areas, on puncture wounds, on damaged skin, or with heating pad,avoid contact with eyes.

●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.

Questions
Ask Doctor

●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.

Directions

●Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area up to 3-4 times daily.

Do Not Use

●Do not bandage tightly; do not use with heating pad; do not apply to large areas or on broken/irritated skin.

●Do not this product if pregnant or breastfeeding, ask a health professional before use.

●Do not use on large areas, on puncture wounds, on damaged skin, or with heating pad,avoid contact with eyes.

When Using

When using this product

●Do not exceed the recommended daily dosage unless directed by a doctor.

●Children under 12 years of age; consult a doctor.

Active Ingredient

Lidocaine 4%

Other Information

●Keep away from direct sunlight or heat.

●Store in room temperature (59-86°F/15-30*C).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

CORRECT USE STEPS BEFORE :

1. Clean hands and treatment area with mild soap and warm water (to open pores to help absorb numbing cream), then gently dry.

2. Apply a thick layer of about 2mm to the treated area.(Make sure the area and surroundings are white cream)

3. Wipe away residue, wait another 20-30 minutes for the numbness to peak. And begin procedure.

Notice:

Due to the difference of temperature and skin type, the durationof numbness effect will be different.Recommended to test in a small area first to ensure the bestnumbness effect.

Inactive Ingredients

Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer, Triethanolamine.

Principal Display Panel

Keep Out of Reach of Children

In case of accidental ingestion, seek medical attention immediately.


Structured Label Content

Use

For the temporary relief of pain, burning and soreness.

Purpose

Topical Anesthetic

Stop Use

If Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use.

●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.

Warnings

Warnings (For external use only)

●Do not bandage tightly; do not use with heating pad; do not apply to large areas or on broken/irritated skin.

●Do not this product if pregnant or breastfeeding, ask a health professional before use.

●Do not use on large areas, on puncture wounds, on damaged skin, or with heating pad,avoid contact with eyes.

●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.

Questions
Ask Doctor

●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.

Directions

●Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area up to 3-4 times daily.

Do Not Use (Do not use)

●Do not bandage tightly; do not use with heating pad; do not apply to large areas or on broken/irritated skin.

●Do not this product if pregnant or breastfeeding, ask a health professional before use.

●Do not use on large areas, on puncture wounds, on damaged skin, or with heating pad,avoid contact with eyes.

When Using

When using this product

●Do not exceed the recommended daily dosage unless directed by a doctor.

●Children under 12 years of age; consult a doctor.

Active Ingredient

Lidocaine 4%

Other Information (Other information)

●Keep away from direct sunlight or heat.

●Store in room temperature (59-86°F/15-30*C).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

CORRECT USE STEPS BEFORE :

1. Clean hands and treatment area with mild soap and warm water (to open pores to help absorb numbing cream), then gently dry.

2. Apply a thick layer of about 2mm to the treated area.(Make sure the area and surroundings are white cream)

3. Wipe away residue, wait another 20-30 minutes for the numbness to peak. And begin procedure.

Notice:

Due to the difference of temperature and skin type, the durationof numbness effect will be different.Recommended to test in a small area first to ensure the bestnumbness effect.

Inactive Ingredients (Inactive ingredients)

Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer, Triethanolamine.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

In case of accidental ingestion, seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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