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.

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D-COL Personal Hygiene Convenience Kit

D-COL Patient Antiseptic Skin Preparation

Drug Facts

Active Ingredient

Chloroxylenol 0.24%

Purpose

Antiseptic

Uses

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

Other Information

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

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

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
D-COL PERSONAL HYGIENE CONVENIENCE KIT 
pyrithione zinc and chloroxylenol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53205-001
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53205-001-011 in 1 CARTON05/30/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 PACKET 22.2 mL
Part 23 PACKET 45 mL
Part 31 PACKET 1 mL
Part 1 of 3
D-COL 
pyrithione zinc shampoo
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
17.4 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/30/2018
Part 2 of 3
D-COL PATIENT ANTISEPTIC SKIN PREPARATION 
chloroxylenol soap
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol2.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A05/30/2018
Part 3 of 3
D-COL NASAL INNER RIM CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
Product Information
Route of AdministrationNASAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRBenzalkonium Chloride (UNII: F5UM2KM3W7)  
INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
INGRPeach Kernel Oil Glycereth-8 esters (UNII: RY37QKW66H)  
INGRSodium Chloride (UNII: 451W47IQ8X)  
INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
INGRSODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
INGRXylitol (UNII: VCQ006KQ1E)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRSPEARMINT OIL (UNII: C3M81465G5)  
INGRTEA TREE OIL (UNII: VIF565UC2G)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC05/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/30/2018
Labeler - D-COL Inc (829947329)
Establishment
NameAddressID/FEIBusiness Operations
Identipak, Inc.942862350MANUFACTURE(53205-001) , PACK(53205-001)

Revised: 1/2023
Document Id: b06700b0-e401-4454-be84-ec64eb8a929b
Set id: 273fcc6f-9c54-42b0-aa0c-9051457b1341
Version: 4
Effective Time: 20230120
 
D-COL Inc