FDA.reportPublic FDA data

SCALAR Pain Relief Cream

Manufacturer
Miracle Balance, LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:57

Label at a glance#

ProductSCALAR Pain Relief Cream
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warning:

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

- On damaged or broken skin

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not bandage tightly

Stop use and as a doctor if:

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.
  • 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.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Ceteareth-20, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Juniperus Communis (Juniper Berry) Extract, magnesium Chloride, Methyl Glucose Sesquistearate, Methyl Salicylate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Solidago Virgaurea (Goldenrod) Extract, Spiraea Ulmaria (Meadowsweet) Extract, Steareth-2, Steareth-10, Stearic Acid, Taraxacum Officinale (Dandelion) Extract, Vitis Vinifera (Grape) Seed Oil.

Questions or comments?

OTC - QUESTIONS SECTION

PH: 806-625-0087 or www.scalarshop.com This product is manufacetured for: Miracle Balance, LLC, Delray Beach FL 33483

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UL2023UL2023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN4
1039690menthol 50 MG/ML Topical CreamSCD4
1039690menthol 5 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80883-097-00SCALAR Pain Relief Cream1 in 1 BOXCREAM14
80883-097-00SCALAR Pain Relief Cream59.1 mL in 1 JARCREAM59.14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80883-097SCALAR PAIN RELIEF CREAM (MENTHOL) CREAM [MIRACLE BALANCE, LLC]4Current NDC, Legacy NDC, 2 package rows20231106_52a13cfe-3f46-45f8-a5af-ce07ea5758e3.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80883-09780883-097-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
JUNIPER BERRYO84B5194RLIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
METHYL GLUCOSE SESQUISTEARATEV1YW10H14DIACT
METHYL SALICYLATELAV5U5022YIACT
AVOCADO OIL6VNO72PFC1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALIX ALBA BARK205MXS71H7IACT
STEARETH-2V56DFE46J5IACT
STEARETH-10FD0913P475IACT
STEARIC ACID4ELV7Z65APIACT
TARAXACUM OFFICINALE39981FM375IACT
GRAPE SEED OIL930MLC8XGGIACT
MENTHOLL7T10EIP3AACTIB

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
SCALAR Pain Relief CreamMENTHOLMiracle Balance, LLC52a13cfe-3f46-45f8-a5af-ce07ea5758e32023-11-06WarningsExact identifier
ndc (package): 80883-097-00
ndc (product): 80883-097
ndc11 (package): 80883009700
spl id: 0975eb87-fad5-1621-e063-6394a90a9880
spl set id: 52a13cfe-3f46-45f8-a5af-ce07ea5758e3

Reported adverse events (FAERS/openFDA)#

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