MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- dimethicone cream

Medline Remedy Phytoplex Skin Repair by

Drug Labeling and Warnings

Medline Remedy Phytoplex Skin Repair by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 5%

Purpose

Skin protectant

Uses

• Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather.

Warnings

For External Use Only.

Do not use

• on deep or puncture wounds
• on animal bites
• on serious burns

When using this product

• avoid contact with 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 a Poison Control Center right away.

Directions

• apply as needed

Other information

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

algae extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, citrus paradisi (grapefruit) peel oil, citrus reticulata (tangerine) peel oil, citrus sinensis (orange) peel oil, cetyl alcohol, cocos nucifera (coconut oil),
7-dehydrocholesterol, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, isopropyl myristate, jojoba esters, manuka honey, methyldihydrojasmonate, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, purified water, propanediol, stearic acid, tocopherol acetate, vanilla planifolia extract, yeast ferment extract, zea mays (corn) oil.

SPL UNCLASSIFIED SECTION

Phytoplex, Medline Remedy, and Medline are registered trademarks of Medline Industries Inc. 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

Package Label

INGREDIENTS AND APPEARANCE

MEDLINE REMEDY PHYTOPLEX SKIN REPAIR 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GELIDIELLA ACEROSA (UNII: T91K54D6M1)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
HONEY (UNII: Y9H1V576FH)
PHYTONADIONE (UNII: A034SE7857)
ORANGE OIL (UNII: AKN3KSD11B)
CLOVE (UNII: K48IKT5321)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
MANDARIN OIL (UNII: NJO720F72R)
COCONUT OIL (UNII: Q9L0O73W7L)
GRAPEFRUIT OIL (UNII: YR377U58W9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLDECANOL (UNII: 151Z7P1317)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
OLIVE OIL (UNII: 6UYK2W1W1E)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
RAPESEED STEROL (UNII: B46B6DD20U)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-152-14	59 mL in 1 TUBE; Type 0: Not a Combination Product	02/12/2018
2	NDC: 53329-152-44	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/12/2018
3	NDC: 53329-152-64	946.353 mL in 1 TUBE; Type 0: Not a Combination Product	04/03/2018
4	NDC: 53329-152-17	144 in 1 BOX	04/03/2018
4	NDC: 53329-152-04	4.14 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 53329-152-84	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/12/2018

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	manufacture(53329-152)