Elevate Heating Therapy Twist Up

Elevate Heating Therapy Twist Up
SPL v2
SPL
SPL Set ID 99d90b4d-c6f1-8b23-e053-2a95a90a6843
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
Cannabidiol Cannabis Sativa Seed Oil Cetearyl Glucoside Magnesium Chloride Stearic Acid Glyceryl Monostearate Laureth-7 Witch Hazel Polyacrylamide (10000 Mw) Mangifera Indica Seed Butter Olive Oil Corn Oil Coconut Oil C13-14 Isoparaffin Peg-100 Stearate Peppermint Cetostearyl Alcohol Water Shea Butter Tabasco Pepper White Wax Phenoxyethanol Magnesium Sulfate, Unspecified Form

Identifiers & Packaging

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

Description

Active Ingredient Menthol 5%


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 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

Description

Active Ingredient Menthol 5%

Section 43683-2

Dosage and Administration section did not exist prior to 01-06-2020. It was missed and created today.

Bullet mark only was removed.

Removed the word "Directions."

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 51727-6

Inactive Ingredients Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens (Pepper) Fruit 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 2oz Cream Stick

Section 53413-1

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

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 5%

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 physician.
Other Information
  • Keep out of direct sunlight.

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

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 wounds or damaged skin
  • do not use with heating pads or other heating devices
Section 43683-2 (43683-2)

Dosage and Administration section did not exist prior to 01-06-2020. It was missed and created today.

Bullet mark only was removed.

Removed the word "Directions."

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 51727-6 (51727-6)

Inactive Ingredients Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens (Pepper) Fruit 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 2oz Cream Stick

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)

Active Ingredient

Menthol 5%

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 physician.
Other Information (Other information)
  • Keep out of direct sunlight.

Advanced Ingredient Data


Raw Label Data

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