Tegrin by The Village Company / Apex International

Tegrin by

Drug Labeling and Warnings

Tegrin by is a Otc medication manufactured, distributed, or labeled by The Village Company, Apex International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEGRIN- pyrithione zinc lotion/shampoo 
The Village Company

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.

----------

Tegrin BACK LABEL 2in1

Back Label

Purpose

Naturally soothes and moisturizes while treating the symptons of dandruff.

Warnings

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a poison control center right away.

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 using and ask a doctor

  • condition worsens or does not improve after regular use of this product as directed.

Keep this and all drugs our of the reach of children

  • If swallowed, get medical help or contact a poison control center right away.

Directions

  • shake before use
  • wet hair, apply onto scalp, rinse, repeat if desired
  • for maximum dandruff control use every time you shampoo
  • for best results use at least twice per week or as directed by a doctor

Inactive ingredients

Water, propelyne glycol, sodum laurly sulfate, sodium laureth sulfate, cocamidopropyl betain, polyquaternium-10, polyquaternium-39, melaleuca alternifolia (tea tree) leaf oil,nigella sativa seed oil, daucus carota sativa (carrot) seed oil, salvia hispzanica seed oil, rubus idaeus (raspberry) seed oil, vaccinium macrocarpon (cranberry) seed oil, rubus occidentalis seed oil, acrylates/c10-30 alkyl acrylate crosspolymer, sodium hydroxide, methlychloroisothiazoline, methylisothiazolinone, fragrance.

Front Label

Front Label

TEGRIN 
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69752-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.2 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 g  in 1 mL
Product Characteristics
Colorwhite (opaque viscous liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69752-121-14414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/2015
Labeler - The Village Company (172208105)
Registrant - Apex International (015226132)
Establishment
NameAddressID/FEIBusiness Operations
Apex International015226132manufacture(69752-121)

Revised: 5/2016
Document Id: 31e156cb-63aa-036d-e054-00144ff8d46c
Set id: 11f955b0-9bd0-3f93-e054-00144ff88e88
Version: 3
Effective Time: 20160506
 
The Village Company