FDA.reportPublic FDA data

SUPER WHITE STUFF PAIN RELIEF

Manufacturer
BLUE SPRING WELLNESS, L.L.C.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:54

Label at a glance#

ProductSUPER WHITE STUFF PAIN RELIEF
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary relief of minor aches and pains associsted with arthritis, simple backache, sprains, strains and bruises.

Dosage and administration

Apply to affected area not more than 3 or 4 time a day.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol, USP (1.4%)

Purpose:

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains associsted with arthritis, simple backache, sprains, strains and bruises.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on wounded, damaged or irritated skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clears up and occurs again within a few days.

If pregnant or breat-feeding 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Consult a doctor

OTC - ASK DOCTOR SECTION

before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2.

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:

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more than 3 or 4 time a day.

Other Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Chamomilla Recutita (Chamomile) Extract, Chrysanthemum Parthenium (Feverfew) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extarct.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2391332menthol 1.4 % Topical CreamPSN3
2391332menthol 14 MG/ML Topical CreamSCD3
2391332menthol 1.4 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14448-315-00SUPER WHITE STUFF PAIN RELIEF5 mL in 1 PACKETCREAM53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14448-315SUPER WHITE STUFF PAIN RELIEF (MENTHOL) CREAM [BLUE SPRING WELLNESS, L.L.C.]3Current NDC, Legacy NDC, 1 package rows20231111_b4278b70-e9a6-4d1f-bbad-257fe437b86a.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14448-31514448-315-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
CHAMOMILEFGL3685T2XIACT
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
CORIANDER OIL7626GC95E5IACT
EMU OIL344821WD61IACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
LAMIUM ALBUM WHOLE046Y1357I6IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALIX NIGRA BARKQU52J3A5B3IACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITOL506T60A25RIACT
EDETATE SODIUMMP1J8420LUIACT
TILIA CORDATA WHOLEW5E5UB44GDIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
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
SUPER WHITE STUFF PAIN RELIEFMENTHOLBLUE SPRING WELLNESS, L.L.C.b4278b70-e9a6-4d1f-bbad-257fe437b86a2023-11-10WarningsExact identifier
ndc (package): 14448-315-00
ndc (product): 14448-315
ndc11 (package): 14448031500
spl id: 09d6fabb-0d2a-222e-e063-6294a90a95b6
spl set id: b4278b70-e9a6-4d1f-bbad-257fe437b86a

Reported adverse events (FAERS/openFDA)#

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