Drugplain

Lidotral 3.88% Roll on 38.8 mg/g

Lidocaine HCI · GEL · PureTek Corporation

No Recall HistoryCurrently in Shortage
Plain English

Lidotral 3.88% Roll on is a gel containing lidocaine hci at 38.8 mg/g, taken topical. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Lidotral 3.88% Roll on
Generic Name
Lidocaine HCI
NDC Code (Product)
59088-307
Manufacturer
PureTek Corporation
Strength
38.8 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Marketing Start
02/28/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

abdominal distension2 reports
asthenia2 reports
diarrhoea2 reports
fatigue2 reports
nausea2 reports
abdominal pain1 reports
acne1 reports
agitation1 reports
alopecia1 reports
blood glucose decreased1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

Dosage & Administration

DOSAGE Adults and children 4 years of age and older: apply a thin film to the affected area(s) two or three times daily or as directed by a licensed healthcare practitioner. See insert for complete product information.

Warnings

WARNINGS For external use only. Not for ophthalmic use.

Contraindications

CONTRAINDICATIONS Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Adverse Reactions

ADVERSE REACTIONS During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

Frequently Asked Questions

What is Lidotral 3.88% Roll on used for?

Lidotral 3.88% Roll on contains Lidocaine HCI. It is a gel taken topical. Consult your doctor for specific uses.

Is Lidotral 3.88% Roll on a controlled substance?

Lidotral 3.88% Roll on is not classified as a controlled substance by the DEA.

What is the generic name for Lidotral 3.88% Roll on?

The generic name for Lidotral 3.88% Roll on is Lidocaine HCI. There are 12 other brand versions of Lidocaine HCI.

What is the NDC code for Lidotral 3.88% Roll on 38.8 mg/g?

The NDC (National Drug Code) for Lidotral 3.88% Roll on 38.8 mg/g is 59088-307, listed by PureTek Corporation.