Active Ingredients

Dimethicone 12.5% w/v

Purpose

Skin Protectant

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

Warnings

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

do not get into eyes

Stop use and ask a doctor if

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.

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

Directions

for skin protection
apply as needed

Other information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

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

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

HYDRAGUARD-D
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CLOVE (UNII: K48IKT5321)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
HONEY (UNII: Y9H1V576FH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHYTONADIONE (UNII: A034SE7857)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RAPESEED STEROL (UNII: B46B6DD20U)
HEXYLDECANOL (UNII: 151Z7P1317)
PROPANEDIOL (UNII: 5965N8W85T)
CORN OIL (UNII: 8470G57WFM)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
LEVOMENOL (UNII: 24WE03BX2T)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-021-14	59 mL in 1 TUBE; Type 0: Not a Combination Product	11/26/2019	05/31/2025
2	NDC:53329-021-44	118 mL in 1 TUBE; Type 0: Not a Combination Product	11/26/2019	06/30/2025
3	NDC:53329-021-77	4 mL in 1 PACKET; Type 0: Not a Combination Product	11/26/2019	05/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	11/26/2019	06/30/2025

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

021 Medline Remedy Intensive Skin Therapy Hydraguard-D with Phytoplex