FDA.reportPublic FDA data

Pain and Inflammation Relief Foam

Manufacturer
The Magni Company | Apotheca Company
Effective date
2024-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:11:32

Label at a glance#

ProductPain and Inflammation Relief Foam
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, CROTON TIGLIUM SEED, SODIUM CHLORIDE, PLANTAGO MAJOR WHOLE, TOXICODENDRON PUBESCENS LEAF, SMILAX ORNATA ROOT
Label structure10 sections

Dosage and administration

Apply to affected areas up to 4 times a day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

INDICATIONS:

OTC - PURPOSE SECTION

Temporary relief from minor aches and pains of sore muscles and joints due to inflammation associated with: 

• Arthritis

• Strains

• Sprains

• Trauma

WARNINGS:

WARNINGS SECTION

• Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away • For external use only

• Avoid contact with eyes • If symptoms persist for more than 7 days or worsen, consult your physician

OTHER INFORMATION:

OTHER SAFETY INFORMATION

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Tamper resistant: Do not use if seal is broken. 

KEEP OUT OF REACH OF CHILDREN:

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

Apply to affected areas up to 4 times a day

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints due to inflammation associated with:

• Arthritis

• Strains

• Sprains

• Trauma

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Juice, Caprylyl Glycol, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Dragon’s Blood Croton (Croton lechleri) Sap, Ethanol, Extract Blend (Arnica [Arnica montana] Flower, Ascorbic Acid, Chaparral [Larrea tridentata] Leaf, Comfrey [Symphytum officinale] Leaf, English Lavender [Lavandula angustifolia] Buds, Lemon Balm [Melissa officinalis] Leaf, Poke [Phytolacca americana] Root, Purified Water, St. John’s Wort [Hypericum perforatum] Aerial Parts, White Willow [Salix alba] Bark, Yarrow [Achillea millefolium] Flower), Glycerin, Ionic Colloidal Silver, Methyl Gluceth-10, PEG-8 Dimethicone, PEG-14, PEG-33, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Bicarbonate, Sodium Cocoyl Isethionate, Sorbic Acid, Tocopherols (soy), Whey Protein Concentrate (milk).

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by: The Magni Group, Inc.

McKinney, TX 75072 USA

www.magnilife.com 

1-800-645-9199

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

HOMEOPATHIC

NDC: 43689-0044-1

MAGNILIFE

PAIN &

INFLAMMATION

RELIEF FOAM

Rapid pain relief due

to inflammation

√ Muscle pain
√ Joint pain
√ Arthritis
√ Stiffness
√ Swelling


NET WT 4 FL OZ (118mL)

Pain & Inflammation Relief FoamPain & Inflammation Relief Foam

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43689-0044-12024-02-13C16284748780-1f386c649-bc0d-0266-e053-dadaa90a7c1aDrug Facts:
43689-0044-12023-01-30C16284748780-1f386c649-bc0d-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43689-0044PAIN AND INFLAMMATION RELIEF FOAM (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) LIQUID [THE MAGNI COMPANY]2Legacy NDC20240214_d0346702-c306-44a8-89da-3592e155204f.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43689-004443689-0044-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PLANTAGO MAJOR WHOLEW2469WNO6UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LARREA TRIDENTATA LEAFPK0TXD049PIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COMFREY LEAFDG4F8T839XIACT
CROTON LECHLERI RESINGGG6W25C63IACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
METHYL GLUCETH-10N0MWT4C7WHIACT
GLYCERINPDC6A3C0OXIACT
SILVER3M4G523W1GIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
PHYTOLACCA AMERICANA ROOT11E6VI8VEGIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ST. JOHN'S WORTUFH8805FKAIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
WHEY8617Z5FMF6IACT
SALIX ALBA BARK205MXS71H7IACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
ALCOHOL3K9958V90MIACT

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
4f93e062-ddeb-40a0-af17-f786c9813b47d0346702-c306-44a8-89da-3592e155204f2024-02-13WarningsExact identifier
spl id: 4f93e062-ddeb-40a0-af17-f786c9813b47
spl set id: d0346702-c306-44a8-89da-3592e155204f

Reported adverse events (FAERS/openFDA)#

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