FDA.reportPublic FDA data

MAG 5 PT COOLING FORMULA RECOVERY CREAM

Manufacturer
RENU LABORATORIES, LLC
Effective date
2025-11-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:17:21

Label at a glance#

ProductMag 5 PT Cooling Formula Recovery Cream
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS SECTION

For external use only

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 heatng 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

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

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and older, apply to affected area no more than three 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

Arnica Montana (Arnica) Flower Extract, 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, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Laureth-7, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum

INDICATIONS & USAGE SECTION

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

MAG 5 PT 16.0 OZ. LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16 OZ. COOLING LABEL16 OZ. COOLING LABEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130680431995054GTIN-13: 0680431995054
EAN-13: 0680431995054
GTIN-12: 680431995054
UPC-A: 680431995054
GTIN storage (14 digits): 00680431995054		Mag5PT_16oz Professional_Cooling_FINAL2 (3).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
76348-510-162025-03-25C16284748780-12cef2736-6d23-d83d-e063-dadaa90ab31fMAG 5 PT COOLING FORMULA RECOVERY CREAM
76348-510-162025-01-30C16284748780-12cef2736-6d23-d83d-e063-dadaa90ab31fMAG 5 PT COOLING FORMULA RECOVERY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-510-04Mag 5 PT Cooling Formula Recovery Cream112 g in 1 JARCREAM1128
76348-510-05Mag 5 PT Cooling Formula Recovery Cream1 in 1 BOXCREAM18
76348-510-16Mag 5 PT Cooling Formula Recovery Cream454 g in 1 JARCREAM4548

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-51076348-510-16, 76348-510-04, 76348-510-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM OROTATEGI96W46M5AIACT
MAGNESIUM GLUCONATET42NAD2KHCIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
WITCH HAZEL101I4J0U34IACT
NIACINAMIDE25X51I8RD4IACT
MENTHOLL7T10EIP3AACTIB
CETEARYL GLUCOSIDE09FUA47KNAIACT
PEG-100 STEARATEYD01N1999RIACT
OLIVE OIL6UYK2W1W1EIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
PEPPERMINT OILAV092KU4JHIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
CORN OIL8470G57WFMIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CANNABIDIOL19GBJ60SN5IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WHITE WAX7G1J5DA97FIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LOBELIA INFLATA LEAF7QFT17RLRGIACT
STEARIC ACID4ELV7Z65APIACT
COCONUT OILQ9L0O73W7LIACT
MAGNESIUM MYRISTATEZ1917F0578IACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT

Source Document#

Source XML · Source PDF

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
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
ndc (package): 76348-510-05
ndc (package): 76348-510-04
ndc (package): 76348-510-16
ndc (product): 76348-510
ndc11 (package): 76348051005
ndc11 (package): 76348051016
ndc11 (package): 76348051004
spl id: 43e53829-1764-6b61-e063-6394a90a53de
spl set id: a45cde67-64ec-643b-e053-2a95a90a10b6

Reported adverse events (FAERS/openFDA)#

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