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

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

aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetyl alcohol, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut oil), 7-dehydrocholesterol, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, jojoba esters, manuka honey, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, propanediol, stearic acid, tocopherol acetate, water, 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 Labels

Package Label

MEDLINE REMEDY PHYTOPLEX SKIN REPAIR
dimeticone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-995
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
HEXANEDIOL (UNII: ZIA319275I)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
STEARIC ACID (UNII: 4ELV7Z65AP)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
LEVOMENOL (UNII: 24WE03BX2T)
HEXYLDECANOL (UNII: 151Z7P1317)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
RAPESEED STEROL (UNII: B46B6DD20U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEG-100 STEARATE (UNII: YD01N1999R)
PHYTONADIONE (UNII: A034SE7857)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
CLOVE (UNII: K48IKT5321)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
HONEY (UNII: Y9H1V576FH)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-995-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2019
2	NDC:53329-995-13	59 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2019
3	NDC:53329-995-23	946 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2019
4	NDC:53329-995-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	11/01/2019

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

995 Remedy® with Phytoplex® Intensive Skin Therapy Skin Repair Cream