FDA.reportPublic FDA data

DIABETIC SKIN CARE FORMULA

Manufacturer
K5 BRANDS, LLC
Effective date
2020-01-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:03:37

Label at a glance#

ProductDIABETIC SKIN CARE FORMULA
Active ingredientZINC ACETATE
Label structure8 sections

Indications and uses

Treats and prevents skin breakdown due to circulation and nutrition problems

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

Assist in wound healing

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Acetate .............25%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CETEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
DI-C12-15 ALKYL FUMARATE
PETROLATUM
MINERAL OIL
SHEA BUTTER
DIMETHICONE
CETYLHYDROXYPROLINE PALMITAMIDE
ALPHA LIPOIC ACID
WATER
CARBOMER HOMOPOLYMER
NIACINAMIDE
TOCOPHERYL ACETATE
SOYBEAN

HYALURONIC ACID
HYALURONATE SODIUM
DEXTROSE
PANTHENOL
PYRIDOXINE HYDROCHLORIDE
VITAMIN A ACETATE
VITAMIN D

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Treats and prevents skin breakdown due to circulation and nutrition problems

DOSAGE & ADMINISTRATION SECTION

Apply to affected area at least twice daily for treatment and prevention

WARNINGS

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

In case of indegestion contact a poison control center or physician immediately

If condition worsens or does not improve within 7 days, consult physician.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70334-152-602022-01-28C16284748780-19d75b9d0-fbaa-f424-e053-dadaa90a57ce2f5f19d6-d27a-01a5-e054-00144ff88e88
70334-152-602020-02-04C16284748780-19d75b9d0-fbaa-f424-e053-dadaa90a57ce2f5f19d6-d27a-01a5-e054-00144ff88e88
70334-152-602020-01-31C16284748780-19d75b9d0-fbaa-f424-e053-dadaa90a57ce2f5f19d6-d27a-01a5-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70334-152-60DIABETIC SKIN CARE FORMULA250 mg in 1 BOTTLE, PLASTICSOAP2508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70334-152DIABETIC SKIN CARE FORMULA (ZINC ACETATE) SOAP [K5 BRANDS, LLC]8Legacy NDC, 1 package rows20200205_2f5f19d6-d27a-01a5-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70334-15270334-152-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DI-C12-15 ALKYL FUMARATEA1CB3Z898PIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
NIACINAMIDE25X51I8RD4IACT
WATER059QF0KO0RIACT
.ALPHA.-LIPOIC ACID73Y7P0K73YIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SOYBEANL7HT8F1ZODIACT
HYALURONIC ACIDS270N0TRQYIACT
HYALURONATE SODIUMYSE9PPT4THIACT
DEXTROSEIY9XDZ35W2IACT
PANTHENOLWV9CM0O67ZIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
VITAMIN A ACETATE3LE3D9D6OYIACT
VITAMIN D9VU1KI44GPIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETYLHYDROXYPROLINE PALMITAMIDE74ONU0S62GIACT
ZINC ACETATEFM5526K07AACTIB

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
9d76c247-013c-e14b-e053-2995a90aad9d2f5f19d6-d27a-01a5-e054-00144ff88e882020-01-31WarningsExact identifier
spl id: 9d76c247-013c-e14b-e053-2995a90aad9d
spl set id: 2f5f19d6-d27a-01a5-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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