REMEDY DIMETHICONE MOISTURE BARRIER UNSCENTED- dimethicone cream

Remedy Dimethicone Moisture Barrier by

Drug Labeling and Warnings

Remedy Dimethicone Moisture Barrier 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

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.

SPL UNCLASSIFIED SECTION

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 RJ18WAR

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

REMEDY DIMETHICONE MOISTURE BARRIER  UNSCENTED
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-142
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
EDETATE SODIUM (UNII: MP1J8420LU)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
TOCOPHEROL (UNII: R0ZB2556P8)

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

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

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Labs		962452533	manufacture(53329-142)