FDA.reportPublic FDA data

Hempvana Cold as Ice 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 00:38:26

Label at a glance#

ProductHempvana Cold as Ice Gel
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults: Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water. For children under 18 years of age : Consult a physician.

Storage and handling

Store tightly closed in a cool dry place.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 8% w/w

Purpose

OTC - PURPOSE SECTION

Menthol USP 8% w/w................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains

WARNINGS SECTION

For external use only

Flammable: Keep away from excessive heat or open flame

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes.

  • Do not apply to wounds or damaged skin
  • Do nut use in large quantities, particularly over raw surfaces or blistered areas.
  • Do not bandage tightly

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or nursing,ask a healthcare professional before using.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water.

For children under 18 years of age: Consult a physician.

Other Information

STORAGE AND HANDLING SECTION

Store tightly closed in a cool dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water/aqua/eau, alcohol denat., isopropyl myristate, sodium hydroxide, silica silylate, hemp seed oil, camphor, aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, curcuma longa (turmeric) root extract, ilex paraguariensis leaf extract, melissa officinalis flower/leaf/stem extract, phenoxyethanol, carbomer, ethylhexylglycerin, disodium edta, tocopheryl acetate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).

DESCRIPTION SECTION

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

Does not contain NSAIDS, ibuprofen, Aspirin or Salicylate

For more information visit www.hempvana.com

Dist. By: Telebrands Corp.

79 Two Bridges Road

Fairfield, NJ 07004

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold Therapy For Pain

Hempvana

#1 Hemp Brand in America

Cold as Ice Pain Relief Gel

Enriched with hemp seed oil turmeric and aloe

Menthol USP 8%

For arthritis, back, shoulder, joint & muscle pain

phthalate free - paraben free - vegan - gluten free - cruelty free

4 fl oz (118 mL)

As seen on TV

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73287-012-01Hempvana Cold as Ice Gel118 mL in 1 TUBEGEL1182
73287-012-01Hempvana Cold as Ice Gel1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73287-012HEMPVANA COLD AS ICE GEL (MENTHOL) GEL [TELEBRANDS CORP]2Current NDC, Legacy NDC, 2 package rows20241122_a9e103f2-778f-e49b-e053-2a95a90aa8b7.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73287-01273287-012-01

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
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
CAMPHOR, (-)-213N3S8275IACT
TURMERIC856YO1Z64FIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MELISSA OFFICINALIS FLOWERING TOP5JQG17B06JIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQIACT
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
Hempvana Cold as Ice GelMENTHOLTelebrands Corpa9e103f2-778f-e49b-e053-2a95a90aa8b72024-11-20WarningsExact identifier
ndc (package): 73287-012-01
ndc (product): 73287-012
ndc11 (package): 73287001201
spl id: 275a6d2c-dc48-4b01-e063-6394a90a99a2
spl set id: a9e103f2-778f-e49b-e053-2a95a90aa8b7

Reported adverse events (FAERS/openFDA)#

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