Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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REMEDY CLEANSING BODY- 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 1.5%

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.

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

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
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)

Revised: 11/2019

Document Id: 98568cca-3735-2f54-e053-2995a90a97a0

34390-5

Set id: be4c7270-89fe-4bb4-8f40-96b9280324bd

Version: 4

Effective Time: 20191127

 

Medline Industries, Inc.