HEMPVANA COLD AS ICE PAIN RELIEF GEL-PATCH- menthol patch

Hempvana Cold As Ice by

Drug Labeling and Warnings

Hempvana Cold As Ice by is a Otc medication manufactured, distributed, or labeled by Telebrands Corp, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

STORAGE AND HANDLING

• 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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/15/2019

Labeler - Telebrands Corp (177266558)

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