REMEDY DIMETHICONE MOISTURE BARRIER UNSCENTED- 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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142 Remedy® with Olivamine® Dimethicone Moisture Barrier Cream

Active ingredient

Dimethicone 5%

Purpose

Skin Protectant

Uses

protects from minor skin irritation associated with diaper rash caused from wetness, urine and/or stool
temporarily protects and helps relieve chapped or cracked skin

Warnings

For External Use Only.

Do not use

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

When using this product

do not get into 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

cleanse skin
apply cream liberally until entire area is covered
apply as needed
protect from freezing, avoid excessive heat

Inactive ingredients

aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, cetyl alcohol, cholecalciferol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate se, glycine, helianthus annuus seed oil, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea leaf extract , peg-8, peg-100 stearate, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, rosa canina fruit oil, stearic acid, stearyl alcohol, tetrasodium edta, tocopherol, triethanolamine, water

Manufacturing Information

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for/Fabriqué pour: Medline Industries, Inc.,

Three Lakes Drive, Northfield, IL 60093 USA.

Imported by/Importé par Medline Canada, Oakville, ON L6L 6R2

www.medline.com

1-800-MEDLINE

REF: MSC094851UNSC

RJ18WAR

Package Label

REMEDY DIMETHICONE MOISTURE BARRIER UNSCENTED
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-142
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
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCINE (UNII: TE7660XO1C)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PROLINE (UNII: 9DLQ4CIU6V)
TAURINE (UNII: 1EQV5MLY3D)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-142-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/21/2018	07/24/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/01/2010	07/24/2022

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 10/2022

Document Id: ebe27b4a-ffa7-7d1f-e053-2995a90a4bf6

Set id: c5c55cad-e7af-424d-b939-00c8dab157de

Version: 11

Effective Time: 20221025

Medline Industries, LP