REMEDY NUTRASHIELD- dimethicone cream

Remedy Nutrashield by

Drug Labeling and Warnings

Remedy Nutrashield 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 1.0%

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, c12-13 pareth-3, c12-13 pareth-23, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, cholecalciferol, citric acid, cyclopentasiloxane, diazolidinyl urea, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer, glycine, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, peg-8, peg/ppg-18/18 dimethicone, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, sodium chloride, tocopherol, water.

SPL UNCLASSIFIED SECTION

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured in USA for/Fabriqué aux É.-U. 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 NUTRASHIELD 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-143-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2010

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

Labeler - Medline Industries, Inc. (025460908)