Readyflush XLarge by Medline Industries, Inc. READYFLUSH(R) PROTECT

Readyflush XLarge by

Drug Labeling and Warnings

Readyflush XLarge by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

READYBATH TPC TOTAL PERINEAL CARE- dimethicone cloth 
READYBATH TPC- dimethicone cloth 
READYCLEANSE CLEANSING WIPES- dimethicone cloth 
ALOETOUCH PREMIUM SPUNLACE CLEANSING CLOTHS- dimethicone cloth 
ALOETOUCH PREMIUM SPUNLACE- dimethicone cloth 
READYFLUSH XLARGE PERSONAL CLEANSING CLOTHS- dimethicone cloth 
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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READYFLUSH(R) PROTECT

Active ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • avoid direct contact with eyes
  • discontinue if irritation or redness develops

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 consult 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

Store at room temperature.

Inactive ingredients

Water, Phospholipid CDM, Phospholipid EFA, Polysorbate 20, Disodium EDTA, Sodium Benzoate, Benzalkonium Chloride, Aloe Vera Gel, Citric Acid

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READYBATH TPC  TOTAL PERINEAL CARE
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.544 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-060-093 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200707/01/2014
READYBATH TPC 
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.608 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-061-098 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200707/01/2014
READYCLEANSE  CLEANSING WIPES
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.294 g
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-062-0924 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200707/01/2014
ALOETOUCH  PREMIUM SPUNLACE CLEANSING CLOTHS
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.294 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-063-0948 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200707/01/2014
ALOETOUCH  PREMIUM SPUNLACE
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.352 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-065-5760 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200707/01/2014
READYFLUSH XLARGE  PERSONAL CLEANSING CLOTHS
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.294 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-066-5824 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
2NDC: 53329-066-6260 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200707/01/2014
Labeler - Medline Industries, Inc. (025460908)

Revised: 12/2019
Document Id: 9a28d747-8cf3-effb-e053-2995a90a722c
Set id: 43a3f0f7-f76f-434d-a21f-7eaa3638913d
Version: 4
Effective Time: 20191220