d-col personal hygiene convenience kit

d-col personal hygiene convenience kit
SPL v5
SPL
SPL Set ID 273fcc6f-9c54-42b0-aa0c-9051457b1341
Routes
topical nasal
Published
Effective Date 2025-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pyrithione zinc (10 mg) chloroxylenol (2.4 mg)
Inactive Ingredients
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 propylene glycol ammonium lauryl sulfate citric acid monohydrate edetic acid ammonium chloride propylparaben imidurea

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-05-30

Purpose

Antiseptic

Description

D-COL Patient Antiseptic Skin Preparation


Medication Information

Warnings

For use only in the inner rim of each nostril.

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.
Purpose

Antiseptic

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).
Description

D-COL Patient Antiseptic Skin Preparation

Questions?

(210)-227-3612

Section 42229-5

D-COL Patient Antiseptic Skin Preparation

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs.

Do Not Use
  • If you or the patient is allergic to Chloroxylenol or any other ingredient in this product.
Active Ingredient

Chloroxylenol 0.24%

Inactive Ingredient

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

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.
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


Structured Label Content

Warnings

For use only in the inner rim of each nostril.

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.
Purpose

Antiseptic

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).
Questions?

(210)-227-3612

Section 42229-5 (42229-5)

D-COL Patient Antiseptic Skin Preparation

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs.

Do Not Use (Do not use)
  • If you or the patient is allergic to Chloroxylenol or any other ingredient in this product.
Active Ingredient

Chloroxylenol 0.24%

Inactive Ingredient

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

When Using 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.
Principal Display Panel Kit Carton Label (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


Advanced Ingredient Data


Raw Label Data

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