REMEDY NUTRASHIELD- dimethicone lotion

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

• 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, dimethicone crosspolymer, dimethiconol,
divinyldimethicone/dimethicone copolymer, ethyl vanillin, glycine, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea fruit oil, olea europaea 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 for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. www.medline.com 1-800-MEDLINE RJ18WAR

Package Labels

INGREDIENTS AND APPEARANCE

REMEDY NUTRASHIELD 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-157
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-157-13	59 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2018
2	NDC: 53329-157-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2018
3	NDC: 53329-157-96	144 in 1 BOX	10/10/2018
3		4 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 53329-157-77	4 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2005

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Labs		962452533	manufacture(53329-157)