FDA.reportPublic FDA data

Lidocaine and Menthol Topical Spray

Manufacturer
7T Pharma LLC
Effective date
2018-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:54:10

Label at a glance#

ProductLidocaine HCl 4 Percent and Menthol 4 Percent
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
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 AND MENTHOL - Lidocaine HCl 4% and Menthol 4% topical spray
7T Pharma, LLC 

----------

Lidocaine 4% and Menthol 4% Topical Spray

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic
Topical analgesic

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

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B

Lidocaine 4% and Menthol 4% Topical Spray

NDC 70645-263-11

4 fl oz (118mL)

Manufactured for:
7T Pharma, LLC
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70645-263-11
LIDOCAINE 4%
AND
MENTHOL 4%
topical spray
4 Fl oz. (118 mL)

PRINCIPAL DISPLAY PANEL NDC 70645-263-11 LIDOCAINE 4% AND MENTHOL 4% topical spray 4 Fl oz. (118 mL)PRINCIPAL DISPLAY PANEL NDC 70645-263-11 LIDOCAINE 4% AND MENTHOL 4% topical spray 4 Fl oz. (118 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70645-263-112024-03-06C16284748780-1f386c649-d316-0266-e053-dadaa90a7c1aLidocaine and Menthol Topical Spray
70645-263-112023-01-30C16284748780-1f386c649-d316-0266-e053-dadaa90a7c1aLidocaine and Menthol Topical Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70645-263-11ML - Milliliter70645-263eb0d3dc9-1aef-44a2-9f9f-051aa2feb29112018-07-03

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70645-26370645-263-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETYL MYRISTOLEATE87P8K33Q5XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MIACT

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
6df1ae34-f8da-4606-b413-ba0c461f228fd605fd20-e97e-40ee-9cee-fbc109c840002024-03-11WarningsExact identifier
spl set id: d605fd20-e97e-40ee-9cee-fbc109c84000

Reported adverse events (FAERS/openFDA)#

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