FDA.reportPublic FDA data

RooveMag Magnesium Soothing Cream Lavender

Manufacturer
RENU LABORATORIES, INC.
Effective date
2023-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:21:08

Label at a glance#

ProductRooveMag Magnesium Soothing Cream Lavender
Active ingredientMAGNESIUM SULFATE ANHYDROUS, ARNICA MONTANA FLOWER, WITCH HAZEL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana

Hamamelis Virginiana (Witch Hazel)

Magnesia Sulphurica (Magnesium Sulfate)

OTC - PURPOSE SECTION

Arnica . Pain, Inflammation

Witch Hazel Pain, Fatigue

Magnesim Sulfate Pain

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

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

  • pain, redness, or swelling worsens
  • 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 - DO NOT USE SECTION

Do not use on broken skin or open wounds.

OTC - STOP USE SECTION

Stop and ask a doctor if

Pain persists for more than 5 days

  • pain, redness, or swelling worsens
  • new symptoms occur

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.

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Glyceryl Stearate, Laureth-7, Lavandula Angustifolia (Lavender) Flower Oil,

Lobelia Inflata (Lobelia) Extract, Mangifera Indica (Mango) Seed Butter, Menthol, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sodium EDTA, Sodium Hyaluronate (Hyaluronic Acid), Stearic Acid, Tocopherol, Tripeptide Marine Collagen, Vaccinium Angustifolium (Blueberr) Fruit Extract, Vegetable Oils

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

STATEMENT OF IDENTITY SECTION

ROOVEMAG

Magnesium

Soothing Cream

Lavender Formula

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROOVEMAG MAGNESIUM SOOTHING CREAM LAVENDER LABEL

ROOVEMAG LAVENDER LABELROOVEMAG LAVENDER 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
76348-404-012025-01-30C16284748780-12cef2736-7212-d83d-e063-dadaa90ab31fROOVEMAG Magnesium Soothing Cream - Lavender Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-404-01RooveMag Magnesium Soothing Cream Lavender60 g in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-404ROOVEMAG MAGNESIUM SOOTHING CREAM LAVENDER (ARNICA, WITCH HAZEL, MAGNESIUM SULFATE) CREAM [RENU LABORATORIES, INC.]11 package rows20230510_f7a8dfa2-28a3-6070-e053-6394a90a83ce.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-40476348-404-01

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
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IACTIB
LAURETH-7Z95S6G8201IACT
OLIVE OIL6UYK2W1W1EIACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
WITCH HAZEL101I4J0U34ACTIB
MENTHOLL7T10EIP3AIACT
HYALURONATE SODIUMYSE9PPT4THIACT
LAVENDER OILZBP1YXW0H8IACT
EDETATE SODIUMMP1J8420LUIACT
STEARIC ACID4ELV7Z65APIACT
PEG-100 STEARATEYD01N1999RIACT
TOCOPHEROLR0ZB2556P8IACT
BLUEBERRY253RUG1X1AIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
COCONUT OILQ9L0O73W7LIACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
LOBELIA INFLATA9PP1T3TC5UIACT
WHITE WAX7G1J5DA97FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
f7a8dfa2-28a4-6070-e053-6394a90a83cef7a8dfa2-28a3-6070-e053-6394a90a83ce2023-03-24WarningsExact identifier
spl id: f7a8dfa2-28a4-6070-e053-6394a90a83ce
spl set id: f7a8dfa2-28a3-6070-e053-6394a90a83ce

Reported adverse events (FAERS/openFDA)#

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