Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

REMEDY NUTRASHIELD- dimethicone cream 
Medline Industries, Inc.

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.

----------

Drug Facts

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-C13 Pareth-3, C12-C13 Pareth-23, Carthamus Tinctorius Seed Oil, Cetyl Dimethicone, Cholecalciferol, Citric Acid, Cyclopentasiloxane, Diazolidinyl Urea, Dimethiconol, Divinyldimethicone/Dimethicone Copolymer, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8, PEG/PPG-18/18 Dimethicone, Propylene Glycol, Propylparaben, Pyridoxine HCl, Retinyl Palmitate, Sodium Chloride, Tocopherol, Water, Zea Mays Oil.

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc.

Manufactured for: Medline Industries, Inc., Mundelein, IL 60060.

www.medline.com 1-800-MEDLINE

Package/Label Principal Display Panel

NDC: 53329-143-04

MEDLINE

REMEDY

WITH NOURISHING OLIVAMINE

NUTRASHIELD

SKIN PROTECTANT CREAM

Dimethicone

Unscented

Moisturizes, nourishes and provides protective moisture barrier

4 fl oz (118 mL)

Label

REMEDY NUTRASHIELD 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-143-04118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2010
Labeler - Medline Industries, Inc. (025460908)

Revised: 2/2016
 
Medline Industries, Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.