PURTECT - petrolatum, chloroxylenol  ointment 
PurKlenz Formulations 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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Active Ingredients

Drug Facts

Active ingredients

Petrolatum 63%    Chloroxylenol 0.8%

Purpose

Purpose

Skin Protectant  Antiseptic

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.

Uses

Uses

Temporarily protects:

Warnings

Warnings

Do not use on
Do not use if you are allergic to any ingredients listed
Stop use and ask a doctor if

Directions

Directions

Other Information

Other information

Inactive Ingredients

Inactive Ingredients: Paraffium Liquidum, Paraffin, Propylene Glycol, Tocopheryl Acetate, Squalane, Retinyl Palmitate, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract

Package Label

PurTect

Topical Ointment and Skin Protectant

Helps protect the Skin's Moisture Barrier

Enriched with Vitamins A and E

Helps Prevent Damage Caused by Dryness

4 Fl. Oz (118 mL)

NDC 49436-xxx-xx

Made in Canada    Distributed in the U.S.A. by PurKlenz Formulations Inc.

Questions or comments? www.purklenz.com


PurKlenz PurTect5 Label




PurKlenz PurTect4 Label




PURTECT 
petrolatum, chloroxylenol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49436-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM63 mL  in 100 mL
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49436-290-01118 mL in 1 TUBE
2NDC:49436-290-0220 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/01/2012
Labeler - PurKlenz Formulations Inc. (078444179)
Registrant - PurKlenz Formulations Inc. (078444179)

Revised: 5/2012
Document Id: d21e1381-d9f9-495e-9037-23e1443483d7
Set id: 80b85f90-d9cc-4eac-96a4-6bdd480f454b
Version: 2
Effective Time: 20120515
 
PurKlenz Formulations Inc.