Magsoothium Body Cream by RENU LABORATORIES, INC. MAGSOOTHIUM BODY CREAM

Magsoothium Body Cream by

Drug Labeling and Warnings

Magsoothium Body Cream by is a Homeopathic medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAGSOOTHIUM BODY CREAM- arnica, witch hazel, magnesium sulf. cream 
RENU LABORATORIES, INC.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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MAGSOOTHIUM BODY CREAM

Arnica Montana 1X

Hamamelis Virginiana 1X

Magnesia Sulphurica 1X

Stop and ask a doctor if

• Pain persists for more than 3 days
• If pain, redness, or swelling occurs
• If new symptoms occur

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

If pregnant or breast-feeding, ask a health professional before use.

Pain, inflammation

pain, fatigue

pain

Uses

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

For external use only. Do not use on broken skin or open wounds.

Directions

Adults and children over the age of 2 years old: Apply generously with gentle rubbing to the affected areas 2-3 times daily or as needed.

Children less than 2 years of age: Consult a doctor.

Aloe Barbadensis Oil, Argana Spinosa (Argan) Kernel Oil, Lobelia Inflata, Mentha Piperita (Peppermint) Oil, Menthol, Olea Europaea (Olive) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil.

Label and Box

MAGSOOTHIUM BODY CREAM 
arnica, witch hazel, magnesium sulf. cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	5.88 g  in 84 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	3.36 g  in 84 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	7.56 g  in 84 g

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
MENTHOL (UNII: L7T10EIP3A)
PETROLATUM (UNII: 4T6H12BN9U)
PEPPERMINT OIL (UNII: AV092KU4JH)
LOBELIA INFLATA (UNII: 9PP1T3TC5U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-432-01	1 in 1 BOX	07/31/2020	10/25/2022
1	NDC: 76348-432-03	84 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/31/2020	10/25/2022

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-432)

Revised: 10/2023

Document Id: 07a08529-2a93-24d6-e063-6294a90a3f09

34390-5

Set id: ad2ec765-3cb0-4bdd-e053-2a95a90ace5d

Version: 3

Effective Time: 20231013