Lidogel™ Lidocaine HCI 2.8% Gel

Manufacturer
PureTek Corporation
Effective date
2021-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:41:11

Label at a glance#

ProductLidogel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritat ion.

Dosage and administration

Adults and children 2 years and older- Apply to affected area not more than 3 to 4 times daily Children under 2 years- Consult a doctor Use under the direction of a medical practitioner

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid excessive heat. Do not use if package is damaged. Keep this and all medication out of reach of children

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 2.8%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts,
    scrapes, insect bites, and minor skin irritat ion.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older- Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years- Consult a doctor

Use under the direction of a medical practitioner

How Supplied:

SPL UNCLASSIFIED SECTION

Lidogel ™ Pain Relieving Gel is supplied in a 3.5 oz (100 g) tube (NDC 59088-452-07)

Other information

STORAGE AND HANDLING SECTION

  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid excessive heat.
  • Do not use if package is damaged.

Keep this and all medication out of reach of children

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Citric Acid, Hydroxyethylcellulose, Methylparaben, PEG-4, Propylene Glycol, Propylparaben, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

For questions or information call toll-free: 877-921-7873

Lidogel™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-45259088-452-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c7a64a0f-1153-3e12-e053-2995a90a7930c2e13ea2-7d2b-ebf8-e053-2995a90a474a2021-07-21WarningsExact identifier
spl set id: c2e13ea2-7d2b-ebf8-e053-2995a90a474a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.