FDA.reportPublic FDA data

ARNIMAX Penetrating Pain Relief Gel

Manufacturer
WYNNPHARM INC.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:49

Label at a glance#

ProductARNIMAX Penetrating Pain Relief Gel
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

Adults and children over 12 years: • Apply and massage a thin layer to affected area no more than 3 to 4 times daily. • Wash hands with soap and water after applying. Ask a doctor. Children under 12:

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warning

WARNINGS SECTION

For external use only.

Do not use if 

OTC - DO NOT USE SECTION

allergic to any ingredients listed in this product.

When using this product

OTC - WHEN USING SECTION

• Use only as direcred • Avoid contact with eyes and mucous membranes • Do not apply directly to wounds or broken skin • Do not bandage tightly or use a heating pad.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Condition worsens • Condition persists for more than 7 days or clears up and occurs again within a few days.

If pregnant or breastfeeding,

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, seek medical attention or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

• Apply and massage a thin layer to affected area no more than 3 to 4 times daily.

• Wash hands with soap and water after applying.

Ask a doctor. Children under 12:

Other information

SPL UNCLASSIFIED SECTION

• Store at 15°-25° C (59°-77°F) • Protect from heat. • Keep tightly closed.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, GLycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hydroxyethyl Cellulose, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonulmethane (MSM), Phenoxyethanol, Propylene Glycol, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259150menthol 3 % Topical GelPSN2
259150menthol 0.03 MG/MG Topical GelSCD2
259150menthol 3 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-274-00ARNIMAX Penetrating Pain Relief Gel75 g in 1 TUBEGEL752
35324-274-00ARNIMAX Penetrating Pain Relief Gel1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35324-274ARNIMAX PENETRATING PAIN RELIEF GEL (MENTHOL) GEL [WYNNPHARM INC.]2Current NDC, Legacy NDC, 2 package rows20231111_3a31f805-19c6-4036-a663-ebef9b212007.zip

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
35324-27435324-274-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
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
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
ndc (package): 35324-274-00
ndc (product): 35324-274
ndc11 (package): 35324027400
spl id: 09d7163b-7e66-1473-e063-6294a90a81a1
spl set id: 3a31f805-19c6-4036-a663-ebef9b212007

Reported adverse events (FAERS/openFDA)#

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