MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- dimeticone 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

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

Package Labels

INGREDIENTS AND APPEARANCE

MEDLINE REMEDY PHYTOPLEX SKIN REPAIR 
dimeticone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-995
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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2019

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	manufacture(53329-995)