ELEVATE CBD HEATING THERAPY- menthol cream

ELEVATE CBD HEATING THERAPY by

Drug Labeling and Warnings

ELEVATE CBD HEATING THERAPY by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC., Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 5%

STOP USE

Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

WARNINGS

Warnings

For external use only

• When using this product do not bandage tightly
• avoid contact with eyes
• do not apply to wounds or damaged skin
• do not use with heating pads or other heating devices.
• Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

When using this product do not bandage tightly

• avoid contact with eyes
• do not apply to wounds or damaged skin
• do not use with heating pads or other heating devices.

PURPOSE

Purpose

Topical Analgesic

QUESTIONS

Questions? Call 215.660.9123 or email us at info@elevatecbd.com

INDICATIONS & USAGE

Uses: For external use on muscles and joints where you feel soreness.

DOSAGE & ADMINISTRATION

Directions

• Massage desired amount into affected skin area no more than 10 times daily or as directed by your doctor.
• children under 12 years of age: consult your doctor

STORAGE AND HANDLING

Other information

Keep out of direct sunlight.

INACTIVE INGREDIENT

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emusifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Mint Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid

DESCRIPTION

Elevate Topical Cream helps unlock the body's ECS receptors to assist in one's well being and is Doctor formulated with menthol and magnesium to aid in relief. Elevate Topical Cream is pharmaceutically produced and lab tested for purity, quality and safety.

PRINCIPAL DISPLAY PANEL

ELEVATE HEATING THERAPY TOPICAL CREAM LABEL

INGREDIENTS AND APPEARANCE

ELEVATE CBD HEATING THERAPY 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PEPPERMINT OIL (UNII: AV092KU4JH)
WHITE WAX (UNII: 7G1J5DA97F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WITCH HAZEL (UNII: 101I4J0U34)
CORN OIL (UNII: 8470G57WFM)
PEG-100 STEARATE (UNII: YD01N1999R)
TABASCO PEPPER (UNII: J1M3NA843L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-455-01	112 g in 1 JAR; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2019

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-455)