Active ingredient

Dimethicone 3.2%

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 on

deep or puncture wounds
animal bites
serious burns

When using this product

avoid direct contact with 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 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 waste receptacle

Other information

Protect from freezing, avoid excessive heat
Keep lid tightly sealed
Not made with Natural Rubber Latex
Do not flush
Cloth: made of Rayon/Polyester

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)

ACTIVE Package Label 53329-060

Label RD12MSC

DEACTIVATED Package Label 53329-061

Label 602283

DEACTIVATED Package Label 53329-062

Label 602813TL

DEACTIVATED Package Label 53329-063

Label 39503TL

DEACTIVATED Package Label 53329-065

Label RD05MSC

DEACTIVATED Package Label 53329-066

Label 066

READYBATH TPC TOTAL PERINEAL CARE
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-060
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.544 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-060-09	3 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	01/01/2007

READYBATH TPC
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-061
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.608 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-061-09	8 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007	07/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2007	07/01/2014

READYCLEANSE CLEANSING WIPES
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-062
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.294 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-062-09	24 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007	07/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2007	07/01/2014

ALOETOUCH PREMIUM SPUNLACE CLEANSING CLOTHS
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.294 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-063-09	48 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007	07/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2007	07/01/2014

ALOETOUCH PREMIUM SPUNLACE
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-065
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.352 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-065-57	60 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007	07/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2007	07/01/2014

READYFLUSH XLARGE PERSONAL CLEANSING CLOTHS
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-066
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.294 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-066-58	24 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007	07/01/2014
2	NDC:53329-066-62	60 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2007	07/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2007	07/01/2014

Labeler - Medline Industries, Inc. (025460908)

READYFLUSH(R) PROTECT