Pyrithione Zinc and Chloroxylenol

FDA Drug Profile — D-COL Personal Hygiene Convenience kit

Drug Details

Generic Name
Pyrithione Zinc and Chloroxylenol
Brand Names
D-COL Personal Hygiene Convenience kit
Application Number
M032
Sponsor
D-COL Inc
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

Uses Antiseptic skin cleansers help reduce bacteria that potentially causes disease. For patient antiseptic skin preparation (15 mL packets only). For healthcare personnel hand wash. For surgical hand scrub. Uses For nasal inner rim cleanser. Uses helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

Do not use If you or the patient is allergic to Chloroxylenol or any other ingredient in this product. When using this product Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. If contact occurs in any of these areas, rinse with cold water right away. Repeated general cleansing of large body areas should not be done except when advised by a health care provider. Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warnings For use only in the inner rim of each nostril. When using this product Avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask doctor if irritation, discomfort, or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warnings For external use only. When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.