HEMPVANA COLD AS ICE GEL- menthol gel

Hempvana Cold as Ice Gel by

Drug Labeling and Warnings

Hempvana Cold as Ice Gel by is a Otc medication manufactured, distributed, or labeled by Telebrands Corp, Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol USP 8% w/w

Purpose

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

Uses

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

simple backache arthritis strains bruises sprains

WARNINGS

For external use only

Flammable: Keep away from excessive heat or open flame

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

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

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

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

Directions

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

Store tightly closed in a cool dry place.

Inactive Ingredients

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

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

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

INGREDIENTS AND APPEARANCE

HEMPVANA COLD AS ICE GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73287-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
CAMPHOR, (-)- (UNII: 213N3S8275)
TURMERIC (UNII: 856YO1Z64F)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALCOHOL (UNII: 3K9958V90M)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73287-012-01	1 in 1 CARTON	07/07/2020
1		118 mL in 1 TUBE; 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	07/07/2020

Labeler - Telebrands Corp (177266558)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(73287-012)