MagNificent Menthol Cooling Pain 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 23:46:55

Label at a glance#

ProductMagNificent Menthol Cooling Pain Cream
Active ingredientMENTHOL
Label structure11 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 physicial or occupational therapist children under 12 years of age: contact physical or occupational therapist

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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 physicial or occupational therapist

  • children under 12 years of age: contact physical or occupational therapist

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea

Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol

(CBD) 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

Cooling Side LabelCooling Side Label

Cooling top labelCooling top label

BOXBOX

INDICATIONS & USAGE SECTION

Uses

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MagNificent BoxMagNificent Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN2
1039690menthol 50 MG/ML Topical CreamSCD2
1039690menthol 5 % Topical CreamSY2

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
76348-421-012024-01-30C16284748780-11030e365-527c-111a-e063-dadaa90a10e2MagNificent Menthol Cooling Pain Cream
76348-421-022024-01-30C16284748780-11030e365-527c-111a-e063-dadaa90a10e2MagNificent Menthol Cooling Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-421-01MagNificent Menthol Cooling Pain Cream112 g in 1 JARCREAM1122
76348-421-02MagNificent Menthol Cooling Pain Cream112 g in 1 BOXCREAM1122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-421MAGNIFICENT MENTHOL COOLING PAIN CREAM (MENTHOL TOPICAL ANALGESIC) CREAM [RENU LABORATORIES, INC.]2Legacy NDC, 2 package rows20220115_7c5f5818-0a0b-556a-e053-2991aa0a69cc.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
76348-42176348-421-01, 76348-421-02

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
d5900d6e-42fe-54a3-e053-2995a90a61af7c5f5818-0a0b-556a-e053-2991aa0a69cc2022-01-14WarningsExact identifier
spl id: d5900d6e-42fe-54a3-e053-2995a90a61af
spl set id: 7c5f5818-0a0b-556a-e053-2991aa0a69cc

Reported adverse events (FAERS/openFDA)#

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