83910-003

83910-003
SPL v1
SPL
SPL Set ID 24177be8-f4fc-0bc4-e063-6294a90ac550
Route
TOPICAL
Published
Effective Date 2024-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Butylene Glycol Xanthan Gum Hyaluronate Sodium Glyceryl 1-stearate Cetearyl Glucoside Tocopherol Menthol Butyrospermum Parkii (shea) Butter Unsaponifiables Jojoba Oil Borneol Squalane Glycerin Dimethicone Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-30

Description

Lidocaine 4%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 4%

Use

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal

area associated with anorectal disorders.

Stop Use

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Warnings

For External Use Only

●Pregnant or breastfeeding, ask a health professional before use.

●In case of accidental overdose, contact a doctor or Poison Control Center immediately.

●Seal is broken or missing.

Questions

www.ohealpro.com

[email protected]

669-588-4076

Ask Doctor

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Directions

1. Before the cream’s application, wash hands thoroughly and wear disposable tattoo gloves.

2. Clean the area of the body receiving the tattoo. Dry completely.

3. Apply a thick amount of numbing cream to the cleaned area and rub in thoroughly, Cover with plastic wrap.

4. Leave cream and wrap in place for 30-45 minutes. Wipe the cream away and clean the area thoroughly, ready for your pain free tattoo.

Do Not Use

●Pregnant or breastfeeding, ask a health professional before use.

●In case of accidental overdose, contact a doctor or Poison Control Center immediately.

●Seal is broken or missing.

When Using

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

●Certain persons can develop allergic reactions to ingredients in this product.

●Do not put this product into the rectum by using fingers or any medical device or applicator.

Active Ingredient

Lidocaine 4%

Other Information

●Keep away from direct sunlight or heat

●Store in room temperature (59-860F / 15-300C)

Inactive Ingredients

Glycerin, Butylene Glycol, Xanthan Gum, Sodium Hyaluronate, Butyrospermum Parkii (Shea Butter) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Dimethicone, Glyceryl Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Tocopherol, Menthol, Borneol

Principal Display Panel

Keep Oot of Reach of Children

In case of accidental ingestion, seek medical attention immediately.


Structured Label Content

Use

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal

area associated with anorectal disorders.

Purpose

Local Anesthetic

Stop Use

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Warnings

For External Use Only

●Pregnant or breastfeeding, ask a health professional before use.

●In case of accidental overdose, contact a doctor or Poison Control Center immediately.

●Seal is broken or missing.

Questions

www.ohealpro.com

[email protected]

669-588-4076

Ask Doctor

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Directions

1. Before the cream’s application, wash hands thoroughly and wear disposable tattoo gloves.

2. Clean the area of the body receiving the tattoo. Dry completely.

3. Apply a thick amount of numbing cream to the cleaned area and rub in thoroughly, Cover with plastic wrap.

4. Leave cream and wrap in place for 30-45 minutes. Wipe the cream away and clean the area thoroughly, ready for your pain free tattoo.

Do Not Use (Do not use)

●Pregnant or breastfeeding, ask a health professional before use.

●In case of accidental overdose, contact a doctor or Poison Control Center immediately.

●Seal is broken or missing.

When Using

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

●Certain persons can develop allergic reactions to ingredients in this product.

●Do not put this product into the rectum by using fingers or any medical device or applicator.

Active Ingredient

Lidocaine 4%

Other Information (Other information)

●Keep away from direct sunlight or heat

●Store in room temperature (59-860F / 15-300C)

Inactive Ingredients (Inactive ingredients)

Glycerin, Butylene Glycol, Xanthan Gum, Sodium Hyaluronate, Butyrospermum Parkii (Shea Butter) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Dimethicone, Glyceryl Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Tocopherol, Menthol, Borneol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

In case of accidental ingestion, seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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