REMEDY NUTRASHIELD- dimethicone cream
Medline Industries, LP

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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143 Remedy Nutrashield (unscented)

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.

Manufacturing Information

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

Three Lakes Drive, Northfield, IL 60093 USA

Imported by/Importé par Medline Canada, Oakville, ON L6L 6R2

www.medline.com

-800-MEDLINE

REF: MSC94853UNSC

RJ18WAR

Package Label

REMEDY NUTRASHIELD
dimethicone cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-143-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2010	08/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2010	08/30/2023

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 10/2022

Document Id: ebe283a7-7719-1cbf-e053-2a95a90a6d4b

Set id: adb9270b-be27-45bc-aa9f-71b44f621fb9

Version: 8

Effective Time: 20221025

Medline Industries, LP