FDA.reportPublic FDA data

SUPER WHITE STUFF Pain Relief Cream

Manufacturer
BLUE SPRING WELLNESS, L.L.C.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:47

Label at a glance#

ProductSUPER WHITE STUFF Pain Relief
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains associated with arthritis simple backahe sprains strains bruises

Dosage and administration

Apply to affected area not more than 3 to 4 times a days. before using for children under 12 for arthritic conditions and for all children under 2 years of age for all other uses. Consult a doctor

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

For the temporary relief of minor aches and pains associated with

  • arthritis
  • simple backahe
  • sprains
  • strains
  • 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 occur again within a few days.

If Pregnant or Breast-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 years of age if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2 years of age.

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.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more than 3 to 4 times a days. before using for children under 12 for arthritic conditions and for all children under 2 years of age for all other uses. Consult a doctor

Inactive Ingrediets

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 Extract.

Questions or Comments?

OTC - QUESTIONS SECTION

Call or visit www.bluestuff.com 1-800-452-3700

Package Labeling:85ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2391332menthol 1.4 % Topical CreamPSN4
2391332menthol 14 MG/ML Topical CreamSCD4
2391332menthol 1.4 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14448-302-30SUPER WHITE STUFF Pain Relief85 mL in 1 BOTTLECREAM854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14448-302SUPER WHITE STUFF PAIN RELIEF (MENTHOL) CREAM [BLUE SPRING WELLNESS, L.L.C.]4Current NDC, Legacy NDC, 1 package rows20231111_1231ddd2-7661-45b2-ab15-32f7fdc078a8.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14448-30214448-302-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHAMOMILEFGL3685T2XIACT
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
CORIANDER1OV56052IKIACT
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.1231ddd2-7661-45b2-ab15-32f7fdc078a82023-11-10WarningsExact identifier
ndc (package): 14448-302-30
ndc (product): 14448-302
ndc11 (package): 14448030230
spl id: 09d7052e-ec40-ef60-e063-6294a90af214
spl set id: 1231ddd2-7661-45b2-ab15-32f7fdc078a8

Reported adverse events (FAERS/openFDA)#

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