HYDRAGUARD-D- dimethicone cream

Hydraguard-D by

Drug Labeling and Warnings

Hydraguard-D by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dimethicone 12.5%

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.

Labeling

INGREDIENTS AND APPEARANCE

HYDRAGUARD-D 
dimethicone cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)
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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RAPESEED STEROL (UNII: B46B6DD20U)
HEXYLDECANOL (UNII: 151Z7P1317)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/26/2019

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	manufacture(53329-021)