FDA.reportPublic FDA data

Neotica

Manufacturer
Lost Tree Health, LLC
Effective date
2022-10-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:10

Label at a glance#

ProductNeotica
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Dosage and administration

Adults and children 3 years of age and older:  Apply to affected area not more than 3 to 4 times daily. Children under 3 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.64%

Methyl Salicylate 12.5%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

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
  • excessive irritation of the skin develops

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 3 years of age and older:  Apply to affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store at temperatures not exceeding 86°F / 30°C

Inactive ingredients 

INACTIVE INGREDIENT SECTION

Carbomer 934, glyceryl monostearate, PEG-20 sorbitan beeswax, sodium hydroxide, sodium lauryl sulfate, water

Package Labeling: Neotica Creme, 15g (72398-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: Neotica Creme, 60g (72398-000-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: Neotica Creme, 100g (72398-000-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2105192menthol 5.64 % / methyl salicylate 12.5 % Topical CreamPSN4
2105192menthol 56.4 MG/ML / methyl salicylate 125 MG/ML Topical CreamSCD4
2105192menthol 5.64 % / methyl salicylate 12.5 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72398-000-002024-01-30C16284748780-11030e365-549f-111a-e063-dadaa90a10e2Neotica Creme
72398-000-012024-01-30C16284748780-11030e365-549f-111a-e063-dadaa90a10e2Neotica Creme
72398-000-022024-01-30C16284748780-11030e365-549f-111a-e063-dadaa90a10e2Neotica Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72398-000-00Neotica15 g in 1 TUBECREAM154
72398-000-00Neotica1 in 1 BOXCREAM14
72398-000-01Neotica60 g in 1 TUBECREAM604
72398-000-01Neotica1 in 1 BOXCREAM14
72398-000-02Neotica100 g in 1 TUBECREAM1004
72398-000-02Neotica1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72398-000NEOTICA (MENTHOL, METHYL SALICYLATE) CREAM [LOST TREE HEALTH, LLC]4Legacy NDC, 6 package rows20221027_6f04aad2-d6b2-bdf6-e053-2991aa0a72a6.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72398-00072398-000-00, 72398-000-01, 72398-000-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
ebdaabb1-6587-f73a-e053-2a95a90a70246f04aad2-d6b2-bdf6-e053-2991aa0a72a62022-10-25WarningsExact identifier
spl id: ebdaabb1-6587-f73a-e053-2a95a90a7024
spl set id: 6f04aad2-d6b2-bdf6-e053-2991aa0a72a6

Reported adverse events (FAERS/openFDA)#

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