D-COL Personal Hygiene Convenience Kit: Package Insert and Label Information

D-COL PERSONAL HYGIENE CONVENIENCE KIT- pyrithione zinc and chloroxylenol
D-COL 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.

D-COL Patient Antiseptic Skin Preparation

Drug Facts

Active Ingredient

Chloroxylenol 0.24%

Purpose

Antiseptic

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.

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.

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

  • Store between 20-25°C (68-77°F).
  • Avoid excessive heat above 40°C (104°F).

Inactive Ingredient

propylene glycol, cocamide dea, ammonium lauryl sulfate, sodium laureth sulfate, citric acid, edta, ammonium chloride, propylparaben, imidazolidinyl urea, fragrance, deionized water

Net Wt. 15 mL per packet

Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212

Questions?

(210)-227-3612

D-COL Nasal Inner Rim Cleanser

Uses

For nasal inner rim cleanser.

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.

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

benzalkonium chloride, polysorbate 20, peach kernel oil glycereth-8 esters, sodium chloride, potassium sorbate, sodium citrate, xylitol, disodium edta, lavandula angustifolia (lavender) oil, mentha viridis (spearmint leaf) oil, melaleuca alternifolia (tea tree leaf) oil, citric acid

Net Wt. 1 mL per packet

Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212

Questions?

(210)-227-3612

D-COL Shampoo

Drug Facts

Active Ingredient

Zinc Pyrithione 1.0%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

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.

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

deionized water, acrylates/C10-30 alkyl acrylate crosspolymer, sodium lauryl ether sulfate, PEG-90 diisostearate, cocamidopropyl betaine, cocamide dea, cyclomethicone 5, edta sodium, caprylyl glycol, sodium hydroxide

Net Wt. 7.4 mL per packet

Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212

Questions?

(210)-227-3612

PRINCIPAL DISPLAY PANEL — Kit Carton Label

DCOL
Personal Hygiene
Convenience Kit

Patient 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

PRINCIPAL DISPLAY PANEL -- Kit Carton Label
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
D-COL Nasal Inner Rim Cleanser CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
D-COL PERSONAL HYGIENE CONVENIENCE KIT
pyrithione zinc and chloroxylenol kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53205-001
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53205-001-01 1 KIT in 1 CARTON None
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 shampoo
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
SODIUM LAURETH-3 SULFATE
PEG-90 Diisostearate
Cocamidopropyl Betaine
COCO DIETHANOLAMIDE
CYCLOMETHICONE 5
EDETATE SODIUM
CAPRYLYL GLYCOL
Sodium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 7.4 mL in 1 PACKET None
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 soap
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chloroxylenol (Chloroxylenol) Chloroxylenol 2.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Propylene Glycol
COCO DIETHANOLAMIDE
Ammonium Lauryl Sulfate
SODIUM LAURETH-3 SULFATE
CITRIC ACID MONOHYDRATE
EDETIC ACID
Ammonium Chloride
Propylparaben
IMIDUREA
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 15 mL in 1 PACKET None
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
liquid
Product Information
Route of Administration NASAL DEA Schedule
Ingredients
Ingredient Name Quantity
Benzalkonium Chloride
Polysorbate 20
Peach Kernel Oil Glycereth-8 esters
Sodium Chloride
Potassium Sorbate
SODIUM CITRATE, UNSPECIFIED FORM
Xylitol
EDETATE DISODIUM
LAVENDER OIL
SPEARMINT OIL
TEA TREE OIL
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 PACKET None
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 Operations
Identipak, Inc. 942862350 MANUFACTURE (53205-001), LABEL (53205-001), PACK (53205-001)

Revised: 01/2020 D-COL Inc

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