FDA.reportPublic FDA data

BLUE SPRING Foot and Leg Comfort Cream with Pain Relief

Manufacturer
BLUE SPRING WELLNESS, L.L.C.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:49

Label at a glance#

ProductBLUE SPRING Foot and Leg Comfort Cream with Pain Relief
Active ingredientMENTHOL, CAPSAICIN
Label structure7 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age. 

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol, USP (1.5%), Capsaicin (0.025%)

Purpose:

OTC - PURPOSE SECTION

  • Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • Temporary relief of minor aches and pains of muscles and joints.

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 bandaged 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 clear 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.

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

  • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age. 

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, Centaurea Cyanus (Cornflower) Extrat, Chamomilla Recutita (Chamomile) Extract, Coriandrum Satiyum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, Hamamelis Virgiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfony Methane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tillia Cordata (Linden) Bark Extarct, Triethanolamine, Fever Few Extract, FD&C Blue#1, FD&C Yellow #5.

Questions or Comments?

OTC - QUESTIONS SECTION

1.800.452.3700 or www.bluespringwellness. com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2583630capsaicin 0.025 % / menthol 1.5 % Topical CreamPSN2
2583630capsaicin 0.25 MG/ML / menthol 15 MG/ML Topical CreamSCD2
2583630capsaicin 0.025 % / menthol 1.5 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
14448-316-00BLUE SPRING Foot and Leg Comfort Cream with Pain Relief227 g in 1 JARCREAM2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14448-316BLUE SPRING FOOT AND LEG COMFORT CREAM WITH PAIN RELIEF (MENTHOL, CAPSAICIN) CREAM [BLUE SPRING WELLNESS, L.L.C.]2Current NDC, Legacy NDC, 1 package rows20231111_2f9cf514-48be-49ec-b424-0b228b4b874a.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14448-31614448-316-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE WHOLE7NF3GE7IWRIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
CHAMOMILEFGL3685T2XIACT
CORIANDER1OV56052IKIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WITCH HAZEL101I4J0U34IACT
SUNFLOWER OIL3W1JG795YIIACT
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBIACT
LAMIUM ALBUM WHOLE046Y1357I6IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALIX ALBA BARK205MXS71H7IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
TROLAMINE9O3K93S3TKIACT
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

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
BLUE SPRING Foot and Leg Comfort Cream with Pain ReliefMENTHOL, CAPSAICINBLUE SPRING WELLNESS, L.L.C.2f9cf514-48be-49ec-b424-0b228b4b874a2023-11-10WarningsExact identifier
ndc (package): 14448-316-00
ndc (product): 14448-316
ndc11 (package): 14448031600
spl id: 09d6fabb-0d3a-222e-e063-6294a90a95b6
spl set id: 2f9cf514-48be-49ec-b424-0b228b4b874a

Reported adverse events (FAERS/openFDA)#

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