MAGSOOTHIUM CBD COOLING ROLL ON RELIEF- magnesium arnica roll on lotion

Magsoothium CBD Cooling Roll On Relief by

Drug Labeling and Warnings

Magsoothium CBD Cooling Roll On Relief by is a Homeopathic medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL ROLL-ON LABEL

PRINCIPAL ROLL-ON LABEL

ACTIVE INGREDIENT

Active Ingredients:

Arnica Montana (Arnica) 1X

Hamamelis Virginiana (Witch Hazel) 1X

Magnesia Sulphurica (Magnesium Sulfate) 1X

PURPOSE

Purpose

Arnica Montana (Arnica) 1X...........Pain, inflammation

Hamamelis Virginiana 1X ............. Pain, Fatigue

Magnesia Sulphurica (Magnesium Sulfate) 1X........Pain

Uses

Natural temporary relief for aches, pains, and inflammation from minor injuries, overexertion, and fatigue.

WARNINGS

Warnings: For external use only - Do not use on broken skin.

Stop and ask a doctor if:

• Pain persists for more than 5 days, If pain redness or swelling worsens
• If new symptoms occur

Directions:

adults and children 12 years of age and older, apply to affected areas no more than 10 times a day as needed for pain

• children under 12 years of age do not use, consult a doctor

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding: Ask a health professional before use

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.

INACTIVE INGREDIENT

Inactive Ingredients: Cannabis Sativa (Hemp) Seed Oil (Broad Spectrum) and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Mentha Piperita (Peppermint) Oil, Menthol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate

QUESTIONS

888-228-9828

Manufactured for

UbU Elements Inc.

Forty Fort, PA 18704

www.magsoothium.com

Uses

Natural temporary relief for aches, pains, and inflammation from minor injuries, overexertion, and fatigue.

PRINCIPAL DISPLAY PANEL

ROLL-ON LABEL

INGREDIENTS AND APPEARANCE

MAGSOOTHIUM CBD COOLING ROLL ON RELIEF 
magnesium arnica roll on lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-425
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	5.6 g  in 84 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	0.84 g  in 84 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	0.084 g  in 84 g

Inactive Ingredients
Ingredient Name	Strength
GRAPEFRUIT (UNII: O82C39RR8C)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CAPSICUM (UNII: 00UK7646FG)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEPPERMINT OIL (UNII: AV092KU4JH)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
MENTHOL (UNII: L7T10EIP3A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CANNABIDIOL (UNII: 19GBJ60SN5)
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-425-01	84 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/03/2017

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-425)