Elevate Cooling Therapy Twist Up

Elevate Cooling Therapy Twist Up
SPL v2
SPL
SPL Set ID 9a13830b-b8b0-276e-e053-2995a90a3573
Route
TOPICAL
Published
Effective Date 2019-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.8 g)
Inactive Ingredients
Peppermint Witch Hazel Shea Butter Cannabis Sativa Seed Oil Cannabidiol Phenoxyethanol Olive Oil Coconut Oil Mangifera Indica Seed Butter Polyacrylamide (10000 Mw) Cetearyl Glucoside Water Magnesium Sulfate, Unspecified Stearic Acid White Wax Cetostearyl Alcohol Glyceryl Stearate/peg-100 Stearate Corn Oil Magnesium Chloride C13-14 Isoparaffin Laureth-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-10-01

Description

Menthol


Medication Information

Warnings and Precautions

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
Indications and Usage

Uses

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

Description

Menthol

Section 43683-2

Bullets removed

The word "Directions" was removed

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

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.
Section 51727-6

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

Section 51945-4

elevate Twist Up Topical label

Section 53413-1

Questions? Call 215.660.9123 or email us at [email protected]

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Menthol

Section 60561-8

Other information

  • Keep out of direct sunlight
Section 69718-5

elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol


Structured Label Content

Indications and Usage (34067-9)

Uses

  • For external use on muscles and joints where you feel soreness
Dosage and Administration (34068-7)

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 and Precautions (34071-1)

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
Section 43683-2 (43683-2)

Bullets removed

The word "Directions" was removed

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

elevate Twist Up Topical label

Section 53413-1 (53413-1)

Questions? Call 215.660.9123 or email us at [email protected]

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Menthol

Section 60561-8 (60561-8)

Other information

  • Keep out of direct sunlight
Section 69718-5 (69718-5)

elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol


Advanced Ingredient Data


Raw Label Data

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