FDA.reportPublic FDA data

Sha'-lem TM OINTMENT

Manufacturer
Shalem Products, Inc.
Effective date
2015-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:27

Label at a glance#

ProductSha-lem
Active ingredientPALMITIC ACID, STEARIC ACID, OLEIC ACID, BISMUTH SUBCARBONATE, BORIC ACID
Label structure10 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips. Temporary protection of minor cuts, scrapes, burns and sunburn. Use on most forms of skin irritations, rashes, non-poisonous insect bites.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Palmitic Acid, Stearic Acid, Oleic Acid, Bismuth Subcarbonate, Boric Acid

Purpose

OTC - PURPOSE SECTION

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach of Children

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips. Temporary protection of minor cuts, scrapes, burns and sunburn. Use on most forms of skin irritations, rashes, non-poisonous insect bites.

Warnings

WARNINGS SECTION

Skin Protectant For External Use Only

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Apply liberally as often as needed. If condition worsens or does not improve within seven days, consult a doctor

Inactive ingredient

INACTIVE INGREDIENT SECTION

White wax

OTC - QUESTIONS SECTION

To Order Call Toll Free: 1-877-741-1682

SPL UNCLASSIFIED SECTION

Shalem Products, Inc., Angora, MN 55703

Reg. U.S. Patent Off.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sha-lemSha-lem

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59862-100-112020-09-27C16284748780-1ab0e2407-3214-f274-e053-dbdaa90a6471Sha'-lem TM OINTMENT
59862-100-112020-09-25C16284748780-1ab0e2407-3214-f274-e053-dbdaa90a6471Sha'-lem TM OINTMENT
59862-100-112020-07-22C16284748780-1ab0e2407-3214-f274-e053-dbdaa90a6471Sha'-lem TM OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59862-100-11Sha-lem30 mL in 1 JAROINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59862-100SHA-LEM (PALMITIC ACID, STEARIC ACID, OLEIC ACID, BISMUTH SUBCARBONATE, BORIC ACID) OINTMENT [SHALEM PRODUCTS, INC.]1Legacy NDC, 1 package rows20151224_e10d94eb-b1cf-4995-81ca-88322a01c37f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59862-10059862-100-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PALMITIC ACID2V16EO95H1ACTIB
STEARIC ACID4ELV7Z65APACTIB
OLEIC ACID2UMI9U37CPACTIB
BISMUTH SUBCARBONATEM41L2IN55TACTIB
BORIC ACIDR57ZHV85D4ACTIB
WHITE WAX7G1J5DA97FIACT

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
af476c82-6637-431f-8ba3-e2816cc19135e10d94eb-b1cf-4995-81ca-88322a01c37f2015-12-15WarningsExact identifier
spl id: af476c82-6637-431f-8ba3-e2816cc19135
spl set id: e10d94eb-b1cf-4995-81ca-88322a01c37f

Reported adverse events (FAERS/openFDA)#

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