FDA.reportPublic FDA data

Spa Dry Heel Foot Relief

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International Inc
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:42:17

Label at a glance#

ProductSpa Dry Heel Foot Relief
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

• apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 4%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only
When using this product● do not get into eyes
Stop use and ask a doctor● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days
Do not use on● deep or puncture wounds ● animal bites ● serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


• apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Glycerin, Polyisobutene, Butyrospermum Parkii (Shea) Butter, Stearyl Stearate, Isopropyl Palmitate, Cetearyl Alcohol, Cetyl Alcohol, Di-PPG-3 Myristyl Ether Adipate, Myristyl Myristate, Ceteareth-20, Behenyl Alcohol, Niacinamide, Sodium PCA, Lactic Acid, Phenoxyethanol , Xanthan Gum, Fragrance, Limonene, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Linalool

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www.jafra.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116731dimethicone 4 % Topical CreamPSN6
1116731dimethicone 40 MG/ML Topical CreamSCD6
1116731dimethicone 4 % Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-002-01Spa Dry Heel Foot Relief1 in 1 CARTONCREAM16
68828-002-01Spa Dry Heel Foot Relief115 mL in 1 JARCREAM1156

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-00268828-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
POLYISOBUTYLENE (55000 MW)TQ77WR8A02IACT
SHEA BUTTERK49155WL9YIACT
STEARYL STEARATE5WX2EGD0DKIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
DI-PPG-3 MYRISTYL ETHER ADIPATET32481VTXWIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
DOCOSANOL9G1OE216XYIACT
NIACINAMIDE25X51I8RD4IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
AVOCADO OIL6VNO72PFC1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PANTHENOLWV9CM0O67ZIACT
EDETATE DISODIUM7FLD91C86KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-01-02full-release2026-06-01 00:50:35

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
Spa Dry Heel Foot ReliefDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a92025-11-05WarningsExact identifier
ndc (package): 68828-002-01
ndc (product): 68828-002
ndc11 (package): 68828000201
spl id: 42d81058-83b7-6142-e063-6294a90a42ae
spl set id: ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9

Reported adverse events (FAERS/openFDA)#

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