ELEVATE COOLING THERAPY TWIST UP- menthol cream

elevate COOLING THERAPY TWIST UP by

Drug Labeling and Warnings

elevate COOLING THERAPY TWIST UP by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol

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.

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose

Topical Analgesic

QUESTIONS

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

WHEN USING

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.

OTHER SAFETY INFORMATION

Other information

• Keep out of direct sunlight

STATEMENT OF IDENTITY

elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol

INDICATIONS & USAGE

Uses

• For external use on muscles and joints where you feel soreness

DOSAGE & ADMINISTRATION

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 physician.

WARNINGS

Warnings

• For external use only
• When using this product do not bandage tightly
• avoid contact with eyes
• do not apply to to wounds or damaged skin
• do not use with heating pads or other heating devices

INACTIVE INGREDIENT

Inactive Ingredients

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, Emulsifying 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

PRINCIPAL DISPLAY PANEL

elevate Twist Up Topical label

INGREDIENTS AND APPEARANCE

ELEVATE COOLING THERAPY TWIST UP 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-456
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.8 g  in 56 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
CORN OIL (UNII: 8470G57WFM)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PEPPERMINT OIL (UNII: AV092KU4JH)
WITCH HAZEL (UNII: 101I4J0U34)
SHEA BUTTER (UNII: K49155WL9Y)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-456-01	56 g in 1 APPLICATOR; 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(76348-456)