FDA.reportPublic FDA data

HARMON DAILY MOISTURIZING LOTION WITH NATURAL SOOTHING OATMEAL

Manufacturer
HARMON STORES, INC.
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:28:05

Label at a glance#

ProductHARMON DAILY MOISTURZIER
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

helps prevent and temporarily protects dry, chafed, cracked, and windburned skin.

Dosage and administration

Apply as needed to hands or body when skin feels dry or irritated.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.3%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects dry, chafed, cracked, and windburned skin.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on deep or puncture wounds, infections, or lacerations, Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes and eyelids. May stain or damage some fabrics, materials or surfaces.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens or does not improve within seven days.

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

  • Apply as needed to hands or body when skin feels dry or irritated.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, magnesium aluminum silicate, sodium chloride, benzyl alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HARMON DAILY MOISTURIZING LOTION WITH NATURAL SOOTHING OATMEAL

3 OZ (85g)

NDC 63940-072-03

Label3Label3

HARMON DAILY MOISTURIZING LOTION WITH NATURAL SOOTHING OATMEAL

18 FL OZ (532mL)

NDC 63940-072-43

Label18FrontLabel18FrontLabel18BackLabel18Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891710dimethicone 1.3 % Topical LotionPSN7
891710dimethicone 13 MG/ML Topical LotionSCD7
891710dimethicone 1.3 % Topical LotionSY7

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-074-03HARMON DAILY MOISTURZIER85 mL in 1 TUBELOTION857
63940-074-43HARMON DAILY MOISTURZIER532 mL in 1 BOTTLE, PUMPLOTION5327

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-074HARMON DAILY MOISTURZIER (DIMETHICONE) LOTION [HARMON STORES, INC.]7Current NDC, Legacy NDC, 2 package rows20241023_bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-07463940-074-03, 63940-074-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATMEAL8PI54V663YIACT
BENZYL ALCOHOLLKG8494WBHIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

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
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
ndc (package): 63940-074-03
ndc (package): 63940-074-43
ndc (product): 63940-074
ndc11 (package): 63940007403
ndc11 (package): 63940007443
spl id: 2502e67d-4813-294c-e063-6394a90aa77e
spl set id: bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7

Reported adverse events (FAERS/openFDA)#

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