FDA.reportPublic FDA data

NIGHTLY FACE TREATMENT - DIMETHICONE

Manufacturer
ARG LABORATORIES INC
Effective date
2023-01-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:53:06

Label at a glance#

ProductNIGHTLY FACE TREATMENT - DIMETHICONE
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

• Temporarily protects and helps relieve chapped or cracked skin. • Helps protect from the drying effect of wind and cold weather.

Dosage and administration

• Apply as needed. After cleansing skin thoroughly, apply four (+/-) pumps to face and neck. Apply to slightly damp skin for optimal absorption. Rinse skin in the morning following usage.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

DIMETHICONE 1.5%

PURPOSE

OTC - PURPOSE SECTION

SKIN PROTECTANT

USES

INDICATIONS & USAGE SECTION

• Temporarily protects and helps relieve chapped or cracked skin.
• Helps protect from the drying effect of wind and cold weather.

WARNINGS

WARNINGS SECTION

For external use only


When using this product
• Do not get into eyes

Stop use and ask a doctor if
• Condition worsens

• Symptoms last more than 7 days or clear up and occur again within a few days

Do not use

• On deep puncture wounds

• Animal bites

• Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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. After cleansing skin thoroughly, apply four (+/-) pumps to face and neck. Apply to slightly damp skin for optimal absorption. Rinse skin in the morning following usage.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER (AQUA), ALOE BARBADENSIS LEAF JUICE, HYDROLYZED EGG SHELL MEMBRANE, NERIUM OLEANDER LEAF EXTRACT, NIACINAMIDE GLYCERIN, PROPANEDIOL,BUTYLENE GLYCOL, GLYCERYL STEARATE, Hydroxyethylacrylate/Sodium
Acryloyldimethyltaurate Copolymer, Hydrogenated Polydecene, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SQUALANE, Cetearyl Olivate, Sorbitan Olivate, C12-15 Alkyl Benzoate, Stearic Acid, LEUCONOSTOC/RADISH ROOT FERMENT, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Polysorbate 80, CAPRYLYL GLYCOL, SALVIA HISPANICA (CHIA) SEED OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, Sodium Lactate, Tocopheryl Acetate, Xanthan Gum, Cymbopogon Schoenanthus Extract, Disodium EDTA, Acetyl Hexapeptide-30, Alteromonas Ferment Extract, Arginine, Caramel, POTASSIUM SORBATE, GLYCERYL CAPRYLATE, PHENYLPROPANOL, Limonene, Citral, Hydroxycitronellal, Linalool.

QUESTIONS?

OTC - QUESTIONS SECTION

1-(844)-599-7787  M-F (9 AM TO 5 PM CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NSC.ADV.NC.Carton.30ml.UNV.V7_Page_1NSC.ADV.NC.Carton.30ml.UNV.V7_Page_1NSC.NeriumRX.NC.Carton.30ml.USA.HK.TK.KW.V12.LR_Page_1NSC.NeriumRX.NC.Carton.30ml.USA.HK.TK.KW.V12.LR_Page_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309917dimethicone 1.5 % Topical CreamPSN5
309917dimethicone 15 MG/ML Topical CreamSCD5
309917dimethicone 1.5 % Topical CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71593-101-512025-01-30C16284748780-1d6a99b39-347e-a426-e053-dadaa90af4c2ARG LABORATORIES (as CMO) - NIGHTLY FACE TREATMENT - DIMETHICONE CREAM (71593-101)
71593-101-512023-01-09C16284748780-1d6a99b39-347e-a426-e053-dadaa90af4c2ARG LABORATORIES (as CMO) - NIGHTLY FACE TREATMENT - DIMETHICONE CREAM (71593-101)
71593-101-512022-01-28C16284748780-1d6a99b39-347e-a426-e053-dadaa90af4c2ARG LABORATORIES (as CMO) - NIGHTLY FACE TREATMENT - DIMETHICONE CREAM (71593-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71593-101-11NIGHTLY FACE TREATMENT - DIMETHICONE30 mL in 1 BOTTLECREAM305
71593-101-51NIGHTLY FACE TREATMENT - DIMETHICONE1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71593-101NIGHTLY FACE TREATMENT - DIMETHICONE (DIMETHICONE) CREAM [ARG LABORATORIES INC]5Legacy NDC, 2 package rows20230111_c9fcd080-1d06-4026-bd09-1fc6cd7f72c2.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71593-10171593-101-11, 71593-101-51

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
EGG SHELL MEMBRANEN7QBR4212VIACT
NERIUM OLEANDER LEAF7KV510R6H6IACT
NIACINAMIDE25X51I8RD4IACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
COCONUT OILQ9L0O73W7LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
SQUALANEGW89575KF9IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
STEARIC ACID4ELV7Z65APIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT
POLYSORBATE 806OZP39ZG8HIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SALVIA HISPANICA SEEDNU0OLX06F8IACT
ROSEMARYIJ67X351P9IACT
SODIUM LACTATETU7HW0W0QTIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
CYMBOPOGON SCHOENANTHUS WHOLERJJ0F54DE8IACT
EDETATE DISODIUM7FLD91C86KIACT
ACETYL HEXAPEPTIDE-494055X1S509IACT
ALTEROMONAS MACLEODIIBPX036043DIACT
ARGININE94ZLA3W45FIACT
CARAMELT9D99G2B1RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
PHENYLPROPANOL0F897O3O4MIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CITRALT7EU0O9VPPIACT

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
f1dd2cd5-417b-06c5-e053-2995a90aed79c9fcd080-1d06-4026-bd09-1fc6cd7f72c22023-01-09WarningsExact identifier
spl id: f1dd2cd5-417b-06c5-e053-2995a90aed79
spl set id: c9fcd080-1d06-4026-bd09-1fc6cd7f72c2

Reported adverse events (FAERS/openFDA)#

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