REMEDY CLEANSING BODY- dimethicone lotion

Remedy Cleansing Body by

Drug Labeling and Warnings

Remedy Cleansing Body 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 1.5%

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve chapped or cracked skin
• cleanses, moisturizes, nourishes and protects skin
• It can be used on face, body and perineal areas

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 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

• Apply cleanser to damp clothe or to skin/perineal area and then gently wipe clean. No rinsing necessary.
• Apply as needed.
• Apply a remedy protectant cream or paste as necessary.

Other information

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, carthamus tinctorius (safflower) seed oil, cetyl alcohol, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, cocamidopropyl pg-dimonium chloride phosphate, diazolidinyl urea, ethyl vanillin, glycerin, glyceryl stearate, glycine, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, oleth-5, peg-8, peg-100 stearate, polysorbate 60, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, stearic acid, stearyl alcohol, tetrasodium edta, tocopherol, triethanolamine, 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 RB19WAR

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

REMEDY CLEANSING BODY 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYTYROSOL (UNII: QEU0NE4O90)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
GRAPEFRUIT OIL (UNII: YR377U58W9)
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)
ORANGE OIL (UNII: AKN3KSD11B)
MANDARIN OIL (UNII: NJO720F72R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
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)
OLETH-5 (UNII: 1GH33785AY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-160-23	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2012
2	NDC: 53329-160-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2008

Labeler - Medline Industries, Inc. (025460908)