FDA.reportPublic FDA data

ROOVEMAG Magnesium Soothing Warming Cream

Manufacturer
RENU LABORATORIES, INC.
Effective date
2023-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:57

Label at a glance#

ProductROOVEMAG Magnesium Soothing Warming Cream
Active ingredientHAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ARNICA MONTANA, MAGNESIUM SULFATE HEPTAHYDRATE
Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children over the age of 2 years old: Apply generously with gentle rubbing to the affected area 2 - 3 times daily or as needed. Children less than 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Arnica Montana (Arnica) 1X
Hamamelis Virginiana (Witch Hazel) 1X
Magnesia Sulphurica (Magnesium Sulfate) 1X

Purpose

OTC - PURPOSE SECTION

Pain, inflammation

Pain, Fatigue

Pain

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Stop and ask a doctor if

Pain Persists for more than 5 days

  • If pain, redness, or swelling worsens
  • if new symptoms occur
    If pregnant or Breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Capsicum Frutescens (Pepper) Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Deionized Water, Emulsifying Wax, Fragrance, Glycerin, Laureth-7, Lobelia Inflata Extract, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Menthol, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Sodium Hyaluronate (Hyaluronic) Acid, Tripeptide Marine Collagen, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vegetable Oil, Xanthan Gum.

Questions or Comments

OTC - QUESTIONS SECTION

Questions or Comments

Contact: contact@tijara.llc

Tijara, LLC

447 Broadway,

2nd Floor Suite #1188

New York, New York 10013,

United States

Uses

INDICATIONS & USAGE SECTION

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

Directions

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

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

ROOVEMAG Magnesium Soothing Cream 60 ml LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI-LAYER LABEL FOR ROOVEMAG CREAM 60 ML

Roove Warming LabelRoove Warming Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-403-012025-01-30C16284748780-12cef2736-8437-d83d-e063-dadaa90ab31fROOVEMAG Magnesium Soothing Warming Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-403-01ROOVEMAG Magnesium Soothing Warming Cream60 g in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-403ROOVEMAG MAGNESIUM SOOTHING WARMING CREAM (ARNICA MONTANA, HAMAMELIS VIRGINIANA, MAGNESIA SULPHURICA) CREAM [RENU LABORATORIES, INC.]11 package rows20230421_f437d2a5-75d8-078d-e053-2995a90aab42.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-40376348-403-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYALURONIC ACIDS270N0TRQYIACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
GRAPEFRUITO82C39RR8CIACT
WHITE WAX7G1J5DA97FIACT
COCONUT OILQ9L0O73W7LIACT
OLIVE OIL6UYK2W1W1EIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
LAURETH-7Z95S6G8201IACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
CAPSICUM00UK7646FGIACT
SHEA BUTTERK49155WL9YIACT
ARNICA MONTANAO80TY208ZWACTIB
PEPPERMINT OILAV092KU4JHIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
CORN OIL8470G57WFMIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
LOBELIA INFLATA LEAF7QFT17RLRGIACT
MENTHOLL7T10EIP3AIACT
XANTHAN GUMTTV12P4NEEIACT
VACCINIUM ANGUSTIFOLIUM LEAFB4L873GNG1IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f43797ed-74e5-a541-e053-2995a90acf88f437d2a5-75d8-078d-e053-2995a90aab422023-02-08WarningsExact identifier
spl id: f43797ed-74e5-a541-e053-2995a90acf88
spl set id: f437d2a5-75d8-078d-e053-2995a90aab42

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.