Lido E.R.CREME ROLL ON

Manufacturer
Pharma-Natural
Effective date
2020-02-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:41:07

Label at a glance#

ProductLido E.R.CREME ROLL ON
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

▪ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ▪ children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Lidocaine HCL 4%............................Topical analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces, or blistered areas.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

▪adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

▪children under 2 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

▪ store in a cool dry place between (59-86°F)15-30°C

▪ don’t use if seal over cap is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, eucalyptus oil, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water

Questions or comments?

OTC - QUESTIONS SECTION

+1-888-469-3579 (M-F) 9 A.M. - 5 P.M. EST or www.advocatemeters.com

Distributed by:

SPL UNCLASSIFIED SECTION

Diabetic Supplu of Suncoast, Inc.

PO Box 2102, Vega Alta, PR 00692

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lido E.R.

PAIN

RELIEVING

LIDOCAINE HCL 4%

Topical

Analgesic Cream

Maximum Strength

4 oz. (113 g)

LidoER LabelLidoER Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63788-115-042020-02-14C16284748780-19d75b9cf-e099-f424-e053-dadaa90a57ceLIDO E.R.
63788-115-042020-01-31C16284748780-19d75b9cf-e099-f424-e053-dadaa90a57ceLIDO E.R.

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63788-11563788-115-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
af622cd6-fb9e-d32e-e053-2a95a90a2919730784af-92fd-782e-e053-2991aa0af3142020-09-15WarningsExact identifier
spl set id: 730784af-92fd-782e-e053-2991aa0af314

Reported adverse events (FAERS/openFDA)#

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