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NDC 53329-0075-58 Readyflush Protect Wipes 3.2 g/100mL Details

Readyflush Protect Wipes 3.2 g/100mL

Readyflush Protect Wipes 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	53329-0075
Product ID	53329-075_e9c09dca-f258-4149-e053-2995a90a1a07
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	Readyflush Protect Wipes
Proprietary Name Suffix	Fragrance Free
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	3.2
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 53329-0075-58 (53329007558)

Pricing Information	N/A
NDC Package Code	53329-075-58
Billing NDC	53329007558
Package	24 APPLICATOR in 1 PACKAGE (53329-075-58) / 9.2 mL in 1 APPLICATOR
Marketing Start Date	2012-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 743d21bd-c40a-4415-ad97-0d8aa99a8af7 Details

Active ingredient

Dimethicone 3.2% w/v

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve chapped or cracked skin
protects minor skin irritation associated with perineal dermatitis

Warnings

For external use only

Do not use

deep or puncture wounds
animal bites
serious burns

When using this product

do not get into eyes

Stop use and ask a doctor if

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 cloths and thoroughly cleanse soiled area
Apply as needed
Dispose of cloth in toilet

Other information

Protect from freezing, avoid excessive heat
Keep lid tightly sealed
Latex Free
Cloth: made of 98% cellulosic fibers

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Disodium EDTA, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Simethicone, Sodium Benzoate, Polysorbate 20, Water (Aqua)

Manufacturing Information

Manufactured by: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE

REF: MSC263811

V2 RH22MSC

Package Label

INGREDIENTS AND APPEARANCE

READYFLUSH PROTECT WIPES FRAGRANCE FREE

dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-075
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3.2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-075-58	24 in 1 PACKAGE	08/01/2012
1		9.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:53329-075-62	60 in 1 PACKAGE	08/01/2012	12/31/2016
2		9.2 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	08/01/2012

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 9/2022

Document Id: e9c09dca-f258-4149-e053-2995a90a1a07

Set id: 743d21bd-c40a-4415-ad97-0d8aa99a8af7

Version: 6

Effective Time: 20220928