FDA.reportPublic FDA data

Ultra Strength Pain Relief Gel

Manufacturer
TELEBRANDS CORP | Neutraderm, Inc.
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:31

Label at a glance#

ProductUltra Strength Pain Relief Gel
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily using roller ball applicator Children under 2 years of age: consult a physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

Purpose

OTC - PURPOSE SECTION

Menthol 8%....................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

OTC - WHEN USING SECTION

When using this product

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not use at the same time as other topical analgesics.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily using roller ball applicator
  • Children under 2 years of age:consult a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Cannabis Sativa (Hemp) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Arnica Montana Flower Extract,, Melissa Officinalis (Balm Mint) Extract, Camphor, Phenoxyethanol, Glycerin, Carbomer, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA, Tocopheryl Acetate, Silica, Yellow 5 (CI 19140), Blue 1 (CI 42090)

Questions?

OTC - QUESTIONS SECTION

Call (855) 877-4503 (M-F, 9am-5pm EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Hemp Pain Relief Brand in America 1

1AC Nielsen 2021 food drug mass POS

Hempvana Brand

Ultra Strength Pain Relief Lotion

NEW! 5 Deep Massaging Stainless Steel Rollerballs

Arthritis

+ Hemp Seed Oil For Moisturization

Menthol 8% For Pain

Net Wt. 2.5 OZ (71g)

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73287-023-01Ultra Strength Pain Relief Gel1 in 1 CARTONLOTION12
73287-023-01Ultra Strength Pain Relief Gel71 g in 1 APPLICATORLOTION712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73287-023ULTRA STRENGTH PAIN RELIEF GEL (MENTHOL) LOTION [TELEBRANDS CORP]2Current NDC, Legacy NDC, 2 package rows20241122_d91b2e09-550e-4968-e053-2995a90ae323.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73287-02373287-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MELISSA OFFICINALISYF70189L0NIACT
TURMERIC856YO1Z64FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
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
Ultra Strength Pain Relief GelMENTHOLTELEBRANDS CORPd91b2e09-550e-4968-e053-2995a90ae3232024-11-20WarningsExact identifier
ndc (package): 73287-023-01
ndc (product): 73287-023
ndc11 (package): 73287002301
spl id: 275b89dc-566d-3bc1-e063-6394a90a9cad
spl set id: d91b2e09-550e-4968-e053-2995a90ae323

Reported adverse events (FAERS/openFDA)#

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