Label: D-COL PERSONAL HYGIENE CONVENIENCE KIT- pyrithione zinc and chloroxylenol kit
- NDC Code(s): 53205-001-01
- Packager: D-COL Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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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.
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Directions
- Patient antiseptic skin preparation. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin area and wash gently. Rinse thoroughly with water.
- Surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL of the product with a brush. Rinse thoroughly under running water.
- Healthcare personnel handwash. Wet hands with water. Dispense about 5 mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
- Other Information
- Inactive Ingredient
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Questions?
- SPL UNCLASSIFIED SECTION
- Uses
- Warnings
-
Directions
- Apply a reasonable amount of the product to the end of your index finger for a single nasal inner rim application.
- Save a reasonable amount to apply to the opposite nasal inner rim.
- Insert your index finger into one nostril no further than the inner rim, and cover the inner rim of the nasal passage with the product.
- Do not apply the product beyond the inner rim of the nasal passage.
- Repeat the application of the product to the untreated nasal inner rim.
- Wait 30 seconds after you complete the application, and thoroughly wipe the inner rim of each nostril with a cloth wet with water.
- Children under 6 years of age should be supervised when using this product.
- Inactive Ingredient
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
-
Directions
- Place enough product in your palm to thoroughly cover the scalp area.
- Rub hands together until product covers entire surface of your palms.
- Apply product to the scalp and thoroughly massage and cover the scalp.
- Rinse with water until the product is completely removed from the application area.
- Use one packet as directed.
- Children under 6 years of age should be supervised when using this product.
- Inactive Ingredient
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Questions?
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PRINCIPAL DISPLAY PANEL - Kit Carton Label
DCOL
Personal Hygiene
Convenience KitPatient Antiseptic Skin Preparation
Chloroxylenol .24%
(3 count, Net Wt. 15 mL Per Packet)Shampoo
Zinc Pyrithione 1.0%
(3 count, Net Wt. 7.4 mL Per Packet)Nasal Inner Rim Cleanser
Organic
(1 count, Net Wt. 1 mL)Compare to active ingredient in Hibiclens: FDA:
Chlorhexidine Gluconate can cause rare but serious life
threatening allergic reaction.Single Use Packets
-
INGREDIENTS AND APPEARANCE
D-COL PERSONAL HYGIENE CONVENIENCE KIT
pyrithione zinc and chloroxylenol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53205-001 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53205-001-01 1 in 1 CARTON 05/30/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 PACKET 22.2 mL Part 2 3 PACKET 45 mL Part 3 1 PACKET 1 mL Part 1 of 3 D-COL
pyrithione zinc shampooProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) PEG-90 Diisostearate (UNII: YAE61SLW68) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) EDETATE SODIUM (UNII: MP1J8420LU) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.4 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 05/30/2018 Part 2 of 3 D-COL PATIENT ANTISEPTIC SKIN PREPARATION
chloroxylenol soapProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol 2.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) COCO DIETHANOLAMIDE (UNII: 92005F972D) Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETIC ACID (UNII: 9G34HU7RV0) Ammonium Chloride (UNII: 01Q9PC255D) Propylparaben (UNII: Z8IX2SC1OH) IMIDUREA (UNII: M629807ATL) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 05/30/2018 Part 3 of 3 D-COL NASAL INNER RIM CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) liquidProduct Information Route of Administration NASAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Benzalkonium Chloride (UNII: F5UM2KM3W7) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Peach Kernel Oil Glycereth-8 esters (UNII: RY37QKW66H) INGR Sodium Chloride (UNII: 451W47IQ8X) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) INGR Xylitol (UNII: VCQ006KQ1E) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR SPEARMINT OIL (UNII: C3M81465G5) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 05/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 05/30/2018 Labeler - D-COL Inc (829947329) Establishment Name Address ID/FEI Business Operations Identipak, Inc. 942862350 MANUFACTURE(53205-001) , PACK(53205-001)