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.

Manufacturing Information

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

RK20BLB

Package Label

MEDLINE REMEDY PHYTOPLEX SKIN REPAIR
dimethicone cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-152-14	59 mL in 1 TUBE; Type 0: Not a Combination Product	02/12/2018	05/31/2025
2	NDC:53329-152-44	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/12/2018	06/30/2025
3	NDC:53329-152-64	946.353 mL in 1 TUBE; Type 0: Not a Combination Product	04/03/2018	05/31/2025
4	NDC:53329-152-17	144 in 1 BOX	04/03/2018	05/31/2025
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	03/31/2025
6	NDC:53329-152-04	4.14 mL in 1 PACKET; Type 0: Not a Combination Product	02/12/2018	05/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	02/12/2018	06/30/2025

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

152 Remedy Intensive Skin Therapy Skin Repair Cream, Orange Vanilla Scent