FDA Label for D-col Personal Hygiene Convenience Kit
View Indications, Usage & Precautions
D-col Personal Hygiene Convenience Kit Product Label
The following document was submitted to the FDA by the labeler of this product D-col Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
D-COL Patient Antiseptic Skin Preparation
Drug Facts
Net Wt. 15 mL per packet
Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212
D-COL Nasal Inner Rim Cleanser
Net Wt. 1 mL per packet
Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212
D-COL Shampoo
Drug Facts
Net Wt. 7.4 mL per packet
Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212
Active Ingredient
Chloroxylenol 0.24%
Zinc Pyrithione 1.0%
Purpose
Antiseptic
Anti-dandruff
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.
For nasal inner rim cleanser.
helps prevent recurrence of flaking and itching associated with dandruff.
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.
Avoid contact with eyes. In case of eye contact, flush with water.
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs.
Stop use and ask doctor if irritation, discomfort, or redness develops.
Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
- 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.
- 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.
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
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
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
Questions?
(210)-227-3612
(210)-227-3612
(210)-227-3612
Warnings
For use only in the inner rim of each nostril.
For external use only.
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
* Please review the disclaimer below.