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NDC 53329-0078-02 Remedy Barrier Cream Cloths 3.6 g/100mL Details

Remedy Barrier Cream Cloths 3.6 g/100mL

Remedy Barrier Cream Cloths is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. The primary component is DIMETHICONE.

Product Information

NDC	53329-0078
Product ID	53329-078_e9c051ed-06c4-1422-e053-2995a90a87e7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Remedy Barrier Cream Cloths
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	3.6
Active Ingredient Units	g/100mL
Substance Name	DIMETHICONE
Labeler Name	Medline Industries, LP
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M016
Listing Certified Through	2024-12-31

Package

Package Images

NDC 53329-0078-02 (53329007802)

Pricing Information	N/A
NDC Package Code	53329-078-02
Billing NDC	53329007802
Package	3 APPLICATOR in 1 PACKAGE (53329-078-02) / 6.9 mL in 1 APPLICATOR
Marketing Start Date	2013-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 00e0cd4a-6049-408a-ab3f-9edf97e6438a Details

Active ingredient

Dimethicone 3.6% w/w

Purpose

Skin Protectant

Uses

helps protect from minor skin irritations associated with perineal dermatitis
temporarily protects and helps relieve chapped or cracked skin
helps protect from the drying effects of wind and cold weather

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

algae extract, allantoin, butylene glycol,

butyrospermum parkii (shea butter) extract,

C12-20 alkyl glucoside, C14-22 alcohols,

camellia sinensis (green tea) extract,

caprylic/capric triglyceride, cetyl alcohol,

citric acid, cocoglucoside, coconut alcohol,

7- dehydrocholesterol, disodium

cocoamphodiacetate, ethylene brassylate,

ethylhexylglycerin, eugenia caryophyllus

(clove) flower extract, glycerin, glycine soja

(soybean) oil, helianthus annuus

(sunflower) seed oil, hydrolyzed soy

protein, hydroxyethyl acrylate/sodium

acryloyldimethyltaurate copolymer,

isohexadecane, isopropyl myristate,

lecithin, methyldihydrojasmonate,

phenoxyethanol, phospholipids,

polysorbate 60, tocopheryl acetate, urea,

vanilla plantifolia fruit extract, water, yeast

ferment extract, zea mays (corn) oil.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and imported materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092508, MSC092507

V2 RE22MSC, V2 RF22MSC

Package 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

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

Ingredient Name	Strength
Inactive Ingredients
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)
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)
VANILLA (UNII: Q74T35078H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-078-76	8 in 1 PACKAGE	12/19/2013
1		17 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:53329-078-91	48 in 1 PACKAGE	12/19/2013
2		6.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC:53329-078-02	3 in 1 PACKAGE	12/19/2013
3		6.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	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

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

Ingredient Name	Strength
Inactive Ingredients
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)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	08/31/2016

Labeler - Medline Industries, LP (025460908)

Revised: 6/2022

Document Id: e9c051ed-06c4-1422-e053-2995a90a87e7

Set id: 00e0cd4a-6049-408a-ab3f-9edf97e6438a

Version: 10

Effective Time: 20220630