MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- dimethicone cream 
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Active ingredient

Dimethicone 5%

Purpose

Skin protectant

Uses

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

Other information

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

Package Label

MEDLINE REMEDY PHYTOPLEX SKIN REPAIR 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-152-1459 mL in 1 TUBE; Type 0: Not a Combination Product02/12/2018
2NDC:53329-152-44118 mL in 1 TUBE; Type 0: Not a Combination Product02/12/2018
3NDC:53329-152-64946.353 mL in 1 TUBE; Type 0: Not a Combination Product04/03/2018
4NDC:53329-152-17144 in 1 BOX04/03/2018
4NDC:53329-152-044.14 mL in 1 PACKET; Type 0: Not a Combination Product
5NDC:53329-152-841000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2019
6NDC:53329-152-044.14 mL in 1 PACKET; Type 0: Not a Combination Product02/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01602/12/2018
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 9/2022
Document Id: e9b1a475-b6ae-035e-e053-2a95a90aa421
Set id: 629d0aad-bde9-e07a-e053-2a91aa0a05c8
Version: 9
Effective Time: 20220927
 
Medline Industries, LP