MagNificent Menthol Warming Cream

Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:56

Label at a glance#

ProductMagNificent Menthol Warming Cream
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist. children under 12 years of age: consult your physical or occupational therapist.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Menthol 5%

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

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 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist.
children under 12 years of age: consult your physical or occupational therapist.

Directions

INSTRUCTIONS FOR USE SECTION

  • adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist.
  • children under 12 years of age: consult your physical or occupational therapist.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), Phenoxyethanol, Xanthan Gum

OTC - QUESTIONS SECTION

Manufactured for:

X12LLC West Chester, PA 19380

www.Magx12.com

INDICATIONS & USAGE SECTION

for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg Magnificent_Round_Warming_CBD (2).jpg Magnificent-WARMING CBD_ART_Box_112718 (2).jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Magnificent Round top labelMagnificent Round top labelMagnificent_Round_Warming_CBD (2).jpg

Magnificent Warming BoxMagnificent Warming BoxMAGNIFICENT WARMING LABELMAGNIFICENT WARMING LABEL

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-422-022024-01-30C16284748780-11030e365-620a-111a-e063-dadaa90a10e2MagNificent Menthol Warming Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-422-01MagNificent Menthol Warming Cream112 g in 1 JARCREAM1122
76348-422-02MagNificent Menthol Warming Cream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-422MAGNIFICENT MENTHOL WARMING CREAM (MENTHOL CREAM) CREAM [RENU LABORATORIES, INC.]2Legacy NDC, 2 package rows20220115_8506740a-3f42-a49f-e053-2a91aa0a0ac0.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-42276348-422-01, 76348-422-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
d5900c5f-b18c-3ff5-e053-2995a90af7cc8506740a-3f42-a49f-e053-2a91aa0a0ac02022-01-14WarningsExact identifier
spl id: d5900c5f-b18c-3ff5-e053-2995a90af7cc
spl set id: 8506740a-3f42-a49f-e053-2a91aa0a0ac0

Reported adverse events (FAERS/openFDA)#

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