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

Label 946 mL

REMEDY CLEANSING BODY 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-160-23946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2012
2NDC: 53329-160-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2008
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2019
 
Medline Industries, Inc.


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