REMEDY BARRIER CREAM CLOTHS- dimethicone cloth REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE- dimethicone cloth

Remedy Barrier Cream Cloths by

Drug Labeling and Warnings

Remedy Barrier Cream Cloths 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 3.6%

Purpose

Skin Protectant

Uses

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes

Stop use and ask a doctor

• condition worsens
• symptoms last 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

• Open package as designated
• Remove fresh cloths and thoroughly cleanse soiled area as needed
• Dispose of cloths in waste receptacle, do not flush in toilet
• Single Patient Use only

Other information

• Protect from freezing, avoid excessive heat
• Keep label tightly sealed
• Do Not Flush
• Cloth: made of Rayon/Polyester

Inactive ingredients

Water, Glycerin, Glycine Soja (Soybean) Oil, Algae Extract, Camellia Sinensis (Green Tea) Extract, Eugenia Caryophyllus
(Clove) Flower Extract, Butyrospermum Parkii (Shea Butter) Extract, Lecithin, Hydrolyzed Soy Protein, Allantoin, Phospholipids, C12-20 Alkyl Glucoside, C14-22 Alcohols, Cetyl Alcohol, Disodium Cocoamphodiacetate, Caprylic/Capric Triglyceride, Citric Acid, Cocoglucoside, Coconut Alcohol, Ethylene Brassylate, Ethylhexylglycerin, Butylene Glycol, Isopropyl Myristate, Methyldihydrojasmonate, Yeast Ferment Extract, Phenoxyethanol, Tocopheryl Acetate, Urea, 7- Dehydrocholesterol, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Vanilla Plantifolia Fruit Extract, Hydroxyethyl acrylate/Sodium acryloyldimethyltaurate copolymer, Isohexadecane, Polysorbate 60.

SPL UNCLASSIFIED SECTION

www.medline.com
©2019 Phytoplex and Medline Remedy and Medline are registered trademarks of
Medline Industries, Inc. Manufactured by/Fabriqué par/Fabricado por:
Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Made in USA with domestic and imported materials
To Order Call: 1-800-MEDLINE RI19DYN

Packaging label

INGREDIENTS AND APPEARANCE

REMEDY BARRIER CREAM CLOTHS 
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
CLOVE (UNII: K48IKT5321)
SHEA BUTTER (UNII: K49155WL9Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALLANTOIN (UNII: 344S277G0Z)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
YEAST (UNII: 3NY3SM6B8U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CORN OIL (UNII: 8470G57WFM)
VANILLA (UNII: Q74T35078H)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-078-76	8 in 1 PACKAGE	12/19/2013
1		17 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/19/2013

REMEDY BARRIER CREAM CLOTHS  FRAGRANCE FREE
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
CLOVE (UNII: K48IKT5321)
SHEA BUTTER (UNII: K49155WL9Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALLANTOIN (UNII: 344S277G0Z)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
YEAST (UNII: 3NY3SM6B8U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CORN OIL (UNII: 8470G57WFM)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-074-76	8 in 1 PACKAGE	08/31/2016
1		17 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/31/2016

Labeler - Medline Industries, Inc. (025460908)