FDA.reportPublic FDA data

INSTA RELIEF DM

Manufacturer
DM LAB CORP
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:59

Label at a glance#

ProductINSTA RELIEF DM
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure7 sections

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.00%

Menthol 1.00%

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching assoicated with minor burns sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily
  • Children under two-years of age: consult a physician.

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alchol, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetereth-20, Cetyl Alcohol, Citrus Aurantifolia (Orange) Oil, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, 1-Arginine, Lavandula Angustifolia (Lavender) Oil, Lecithin, Methylsulfonylmethane (MSM), Phenoxyethanol, Potassium Hydroxide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN2
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72465-600-00INSTA RELIEF DM118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72465-600INSTA RELIEF DM (LIDOCAINE HYDROCHLORIDE, MENTHOL) CREAM [DM LAB CORP]2Current NDC, Legacy NDC, 1 package rows20231106_6ef66fb9-9f49-409d-9503-175c7555ee9e.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72465-60072465-600-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETYL ALCOHOL936JST6JCNIACT
LIME OILUZH29XGA8GIACT
CARROTL56Z1JK48BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
LAVENDER OILZBP1YXW0H8IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB

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
INSTA RELIEF DMLIDOCAINE HYDROCHLORIDE, MENTHOLDM LAB CORP6ef66fb9-9f49-409d-9503-175c7555ee9e2023-11-05WarningsExact identifier
ndc (package): 72465-600-00
ndc (product): 72465-600
ndc11 (package): 72465060000
spl id: 097478f1-9b6a-b749-e063-6394a90a9977
spl set id: 6ef66fb9-9f49-409d-9503-175c7555ee9e

Reported adverse events (FAERS/openFDA)#

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