Drugplain

Theraworx Pain Relief Roll- On- Lidocaine 40 mg/mL

LIDOCAINE HYDROCHLORIDE · LIQUID · AVADIM HOLDINGS, INC.

No Recall HistoryCurrently in Shortage
Plain English

Theraworx Pain Relief Roll- On- Lidocaine is a prescription liquid containing lidocaine hydrochloride at 40 mg/mL, taken topical. Manufactured by AVADIM HOLDINGS, INC..

Key Facts

Brand Name
Theraworx Pain Relief Roll- On- Lidocaine
Generic Name
LIDOCAINE HYDROCHLORIDE
NDC Code (Product)
61594-028
Manufacturer
AVADIM HOLDINGS, INC.
Strength
40 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
HUMAN OTC DRUG
Application #
M017
Drug Class
Amide Local Anesthetic [EPC]; Amides [CS]
Marketing Start
01/15/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

infusion site pain682 reports
nausea471 reports
drug ineffective435 reports
infusion site erythema422 reports
headache415 reports
dyspnoea409 reports
off label use400 reports
diarrhoea398 reports
fatigue350 reports
pain331 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For temporary relief of pain

Dosage & Administration

Directions Adults and children 2 years of age and older: shake bottle well roll a thin layer to each affected area and allow to air dry repeat Wash hands after applying product do not use more than 3 to 4 times daily children under 2 years of age do not use: consult a doctor

Warnings

Warnings For external use only. Do not use in large quantities, particularly over raw surfaces or blistered areas When using this product avoid contact with the eyes Stop use and ask a 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 If swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Theraworx Pain Relief Roll- On- Lidocaine used for?

Theraworx Pain Relief Roll- On- Lidocaine contains LIDOCAINE HYDROCHLORIDE. It is a liquid taken topical. Consult your doctor for specific uses.

Is Theraworx Pain Relief Roll- On- Lidocaine a controlled substance?

Theraworx Pain Relief Roll- On- Lidocaine is not classified as a controlled substance by the DEA.

What is the generic name for Theraworx Pain Relief Roll- On- Lidocaine?

The generic name for Theraworx Pain Relief Roll- On- Lidocaine is LIDOCAINE HYDROCHLORIDE. There are 12 other brand versions of LIDOCAINE HYDROCHLORIDE.

What is the NDC code for Theraworx Pain Relief Roll- On- Lidocaine 40 mg/mL?

The NDC (National Drug Code) for Theraworx Pain Relief Roll- On- Lidocaine 40 mg/mL is 61594-028, listed by AVADIM HOLDINGS, INC..