FDA.reportPublic FDA data

Hydraguard-D

Manufacturer
Medline Industries, LP
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:02:47

Label at a glance#

ProductHydraguard-D
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

helps prevent and protect from the drying effects of wind and cold weather temporarily protects and helps relieve chapped or cracked skin temporarily protects minor cuts, scrapes, and burns

Dosage and administration

for skin protection apply as needed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 12.5% w/v

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and protect from the drying effects of wind and cold weather
  • temporarily protects and helps relieve chapped or cracked skin
  • temporarily protects minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protection
  • apply as needed

Other information

OTHER SAFETY INFORMATION

Protect from freezing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

7-Dehydrocholestrol, Aphanizomenon Flos-Aquae (Algae) Extract, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, Carthamus Tinctorius (Safflower) Oleosomes, Cetylhydroxyproline Palmitamide, Cholecalciferol, Dimethicone Crosspolymer, Dimethiconol, Divinyldimethicone/Dimethicone Copolymer Emulsion, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hexyldecanol, Hydrolyzed Soy Protein, Jojoba Esters, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Manuka Honey, Olea Europaea (Olive) Oil, PEG/PPG-18/18 Dimethicone, Phenoxyethanol, Phospholipids, Phytonadione, Propanediol, Purified Water, Sodium Chloride, Stearic Acid, Tocopheryl Acetate, Yeast Ferment Extract, Zea Mays (Corn) Oil.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of Domestic and Imported Materials.

www.medline.com

1-800-MEDLINE

REF: MSC092564

RI18BLB

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-021HYDRAGUARD-D (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]6Legacy NDC20240514_98bc44a0-7c28-2742-e053-2a95a90abd41.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-021-44ML - Milliliter53329-021dea60fdb-29ab-46a3-bc21-5669f807f86812025-02-10

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
53329-02153329-021-14, 53329-021-44, 53329-021-77

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
CHOLECALCIFEROL1C6V77QF41IACT
CLOVEK48IKT5321IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
HONEYY9H1V576FHIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PHYTONADIONEA034SE7857IACT
STEARIC ACID4ELV7Z65APIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
APHANIZOMENON FLOSAQUAE49VG1X560XIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
GLYCERINPDC6A3C0OXIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
RAPESEED STEROLB46B6DD20UIACT
HEXYLDECANOL151Z7P1317IACT
DIMETHICONE92RU3N3Y1OACTIB
PROPANEDIOL5965N8W85TIACT
CORN OIL8470G57WFMIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
7-DEHYDROCHOLESTEROLBK1IU07GKFIACT
LEVOMENOL24WE03BX2TIACT
CETYLHYDROXYPROLINE PALMITAMIDE74ONU0S62GIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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
1858d5fc-6824-6945-e063-6294a90a30be98bc44a0-7c28-2742-e053-2a95a90abd412024-05-13WarningsExact identifier
spl id: 1858d5fc-6824-6945-e063-6294a90a30be
spl set id: 98bc44a0-7c28-2742-e053-2a95a90abd41

Reported adverse events (FAERS/openFDA)#

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