Drugplain

Painless Tattoo 3 2 g/100mL

Tetracaine · CREAM · Sambria Pharmaceuticals, LLC

No Recall History
Plain English

Painless Tattoo 3 is a cream containing tetracaine at 2 g/100mL, taken topical. Manufactured by Sambria Pharmaceuticals, LLC.

Key Facts

Brand Name
Painless Tattoo 3
Generic Name
Tetracaine
NDC Code (Product)
54723-017
Manufacturer
Sambria Pharmaceuticals, LLC
Strength
2 g/100mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Ester Local Anesthetic [EPC]
Marketing Start
09/26/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use46 reports
endophthalmitis32 reports
inflammation24 reports
vision blurred24 reports
corneal epithelium defect22 reports
toxic anterior segment syndrome20 reports
visual impairment19 reports
drug hypersensitivity18 reports
eye pain18 reports
headache18 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For temporary relief of pain and itching due to minor skin irritation.

Dosage & Administration

Directions Adults and children 12 years of age and over: Clean and dry affected area, apply to affected area not more than 3 to 4 times daily. Children 12 years of age or younger : ask a doctor.

Warnings

Warnings For external use only. Do not use on wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product. When using this product use only as directed. Avoid contact with the eyes, rashes, or mucous membranes. Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children and pets If swallowed get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Painless Tattoo 3 used for?

Painless Tattoo 3 contains Tetracaine. It is a cream taken topical. Consult your doctor for specific uses.

Is Painless Tattoo 3 a controlled substance?

Painless Tattoo 3 is not classified as a controlled substance by the DEA.

What is the generic name for Painless Tattoo 3?

The generic name for Painless Tattoo 3 is Tetracaine. There are 11 other brand versions of Tetracaine.

What is the NDC code for Painless Tattoo 3 2 g/100mL?

The NDC (National Drug Code) for Painless Tattoo 3 2 g/100mL is 54723-017, listed by Sambria Pharmaceuticals, LLC.