FDA.reportPublic FDA data

LIDOCAINE Cream

Manufacturer
7T Pharma LLC
Effective date
2018-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:48

Label at a glance#

ProductLIDOCAINE
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

 adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day  children under 2 years  ask a doctor

Storage and handling

May be applied under occlusive dressing. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE - Lidocaine 4% cream
7T Pharma, LLC 

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 4% Cream

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

​For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

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 olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

Lidocaine 4% Cream

NDC 70645-262-11 

Topical Anesthetic Cream

120 grams

7T Pharma, LLC
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70645-262-11
LIDOCAINE 4%
Cream
120 grams

PRINCIPAL DISPLAY PANEL NDC 70645-262-11 LIDOCAINE 4% Cream 120 gramsPRINCIPAL DISPLAY PANEL NDC 70645-262-11 LIDOCAINE 4% Cream 120 grams

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70645-262-112024-03-06C16284748780-1f386c649-d4df-0266-e053-dadaa90a7c1aLIDOCAINE Cream
70645-262-112023-01-30C16284748780-1f386c649-d4df-0266-e053-dadaa90a7c1aLIDOCAINE Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70645-262-11GM - Gram70645-262d43dc1c0-d5b4-4fcc-ae81-c418f7bb430412018-10-11

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70645-26270645-262-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
LAURETH-7Z95S6G8201IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT

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
82e455b4-c339-431c-8dfd-71e0371a3bf18be4ae79-554a-47d6-8057-bc1e6bd3a8592024-03-11WarningsExact identifier
spl set id: 8be4ae79-554a-47d6-8057-bc1e6bd3a859

Reported adverse events (FAERS/openFDA)#

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