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NDC 73287-0014-01 Hempvana Ultra Strength Pain Relief Gel - Arthritis 8 g/8g Details

Hempvana Ultra Strength Pain Relief Gel - Arthritis 8 g/8g

Hempvana Ultra Strength Pain Relief Gel - Arthritis is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Telebrands Corp. The primary component is MENTHOL.

Product Information

NDC	73287-0014
Product ID	73287-014_c22cf1a5-0d5e-5ea5-e053-2995a90a333b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hempvana Ultra Strength Pain Relief Gel - Arthritis
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol 8%
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	8
Active Ingredient Units	g/8g
Substance Name	MENTHOL
Labeler Name	Telebrands Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73287-0014-01 (73287001401)

Pricing Information	N/A
NDC Package Code	73287-014-01
Billing NDC	73287001401
Package	1 JAR in 1 CARTON (73287-014-01) / 119 g in 1 JAR
Marketing Start Date	2021-05-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c22cf1a5-0d5d-5ea5-e053-2995a90a333b Details

Active Ingredient

Menthol 8%

Purpose

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

Uses

Temporary relief of pain

Warnings

For external use only

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

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.

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

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

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

Directions

For Use By Adults Only
Apply generously to affected area.
Massage into painful area until thoroughly absorbed into skin.
Repeat as necessary, but no more than 4 times daily.

Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Sodium Hydroxide, Silica Silylate, Dimethyl Sulfone, Glucosamine Sulfate, Sodium Chondroitin Sulfate, Cannabis Sativa (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, Glycerin, Tocopheryl Acetate, Yellow 5 (CI 19140), Blue 1 (CI 42090)

Questions?

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

PRINCIPAL DISPLAY PANEL

Hempvana

Ultra Strength

Pain Relief

Gel

Arthritis

+ Hemp Seed Oil

Menthol 8%

Net Wt. 4 OZ (119 g)

INGREDIENTS AND APPEARANCE

HEMPVANA ULTRA STRENGTH PAIN RELIEF GEL - ARTHRITIS

menthol 8% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g in 8 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
CAMPHOR, (-)- (UNII: 213N3S8275)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TURMERIC (UNII: 856YO1Z64F)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-014-01	1 in 1 CARTON	05/12/2021
1		119 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/12/2021

Labeler - Telebrands Corp (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
Neutraderm, Inc.		146224444	manufacture(73287-014)

Revised: 5/2021

Document Id: c22cf1a5-0d5e-5ea5-e053-2995a90a333b

Set id: c22cf1a5-0d5d-5ea5-e053-2995a90a333b

Version: 1

Effective Time: 20210512