REMEDY SKIN REPAIR- dimethicone cream

Remedy Skin Repair by

Drug Labeling and Warnings

Remedy 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 1.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

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, Canola Oil, Cetyl Alcohol, Cholecalciferol, Citric Acid,

Diazolidinyl Urea, Glycerin, Glyceryl Stearate SE, Glycine, Hydroxytyrosol,

L-proline, L-taurine, Methylparaben, Methylsulfonylmethane,

N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8,

PEG-100 Stearate, Propylene Glycol, Propylparaben, Pyridoxine HCl,

Retinyl Palmitate, 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: Medline Industries, Inc., Northfield, IL 60093.

www.medline.com 1-800-MEDLINE

Package/Label Principal Display Panel

NDC: 53329-140-04

MEDLINE

REMEDY

WITH NOURISHING OLIVAMINE

SKIN REPAIR CREAM FRAGRANCE FREE

DIMETHICONE

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

NDC: 53329-140-23

MEDLINE

REMEDY

WITH NOURISHING OLIVAMINE

SKIN REPAIR CREAM FRAGRANCE FREE

DIMETHICONE

32 fl oz (946 mL)

INGREDIENTS AND APPEARANCE

REMEDY SKIN REPAIR 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CANOLA OIL (UNII: 331KBJ17RK)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCINE (UNII: TE7660XO1C)
PROLINE (UNII: 9DLQ4CIU6V)
TAURINE (UNII: 1EQV5MLY3D)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
NIACINAMIDE (UNII: 25X51I8RD4)
OLIVE OIL (UNII: 6UYK2W1W1E)
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)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-140-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2010
2	NDC: 53329-140-23	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/08/2017

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)