Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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REMEDY NUTRASHIELD- dimethicone lotion 
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.

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Drug Facts

Active ingredient

Dimethicone 1.0%

Purpose

Skin Protectant

Uses

  • Helps treat and prevent 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
  • on serious burns

When using this product

  • do not get into eyes

Stop use and ask a doctor

  • 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

  • Apply liberally as needed.

Other information

  • 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, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil,

Citrus Tangerina Peel Oil, 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, Vanillin, 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: 53329-157-04

MEDLINE

REMEDY®

WITH OLIVAMINE ®

NUTRASHIELD

WITH SILICONE BLENDS

Long-lasting nourishing formula that helps prevent diaper rash, dry and cracked skin.

NON-ALLERGENIC

NON-SENSITIZING

4 fl oz (118 mL)

Label

REMEDY NUTRASHIELD 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-157
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)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ORANGE OIL (UNII: AKN3KSD11B)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCINE (UNII: TE7660XO1C)  
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)  
VANILLIN (UNII: CHI530446X)  
WATER (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-157-1359 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2018
2NDC: 53329-157-04118 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2018
3NDC: 53329-157-96144 in 1 BOX10/10/2018
34 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC: 53329-157-774 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2005
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Labs962452533manufacture(53329-157)

Revised: 9/2018
 
Medline Industries, Inc.


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