Search by Drug Name or NDC

NDC 73287-0005-01 Hempvana Cold As Ice 5 g/100g Details

Hempvana Cold As Ice 5 g/100g

Hempvana Cold As Ice is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Telebrands Corp. The primary component is MENTHOL.

Product Information

NDC	73287-0005
Product ID	73287-005_976a43ad-a7d8-78fb-e053-2a95a90a2343
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 Cold As Ice
Proprietary Name Suffix	Pain Relief Gel-Patch
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/100g
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 73287-0005-01 (73287000501)

Pricing Information	N/A
NDC Package Code	73287-005-01
Billing NDC	73287000501
Package	7 PATCH in 1 CARTON (73287-005-01) / 8 g in 1 PATCH
Marketing Start Date	2019-11-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 976a1bb2-b776-8199-e053-2995a90a1a1b Details

Drug Facts

Active Ingredient:

Menthol 5%

Purpose

Menthol 5%................Topical Anesthetic

Uses

temporarily relief of pain

Warnings

For external use only

Do not use

more than one patch at a time
on wounds, cuts, damaged, broken and/or irritated skin
over raw surfaces or blistered areas
at the same time as other topical analgesics
if allergic to menthol or any inactive ingredients
if package is damaged or opened

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

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 ingested, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 12 years of age

Clean and dry affected area
follow application insructions above to apply patch to skin
Apply one patch to affected area no more than 3-4 times daily
Remove patch from affected area after maximum of 8 hour application
Children uner 12 years of age: consult a doctor

SPL UNCLASSIFIED SECTION

Avoid storing patches in direct sunlight. Protect patches from excessive moisture

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, Water

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMPVANA COLD AS ICE PAIN RELIEF GEL-PATCH

menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-005-01	7 in 1 CARTON	11/15/2019
1		8 g in 1 PATCH; 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	11/15/2019

Labeler - Telebrands Corp (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(73287-005)

Revised: 11/2019

Document Id: 976a43ad-a7d8-78fb-e053-2a95a90a2343

Set id: 976a1bb2-b776-8199-e053-2995a90a1a1b

Version: 1

Effective Time: 20191115