EL VALLE GENTIAN VIOLET- gentian violet 1% liquid 
Pharmadel LLC

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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El Valle Gentian Violet 1%

Drug Facts

Drug facts

Active Ingredient & Purpose

Gentian Violet 1%

Active ingredientPurpose
Gentian Violet 1% .............................First aid antespetic

Uses

First aid to help prevent infection in

Warnings

FOR EXTERNAL USE ONLY.

Do not use

  • longer than 1 week, unless directed by a doctor
  • in the eyes

Ask a doctor before use if you have

  • a deep or puncture wounds
  • serious burns
  • animal bites

Stop use and consult a doctor if

  • conditions persist or gets worse

Keep out of reach of children.

If swallowed, get medical help, or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

alcohol, water

Principal Display Panel

EVGV PDP

EL VALLE GENTIAN VIOLET 
gentian violet 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-373
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-373-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2023
2NDC:55758-373-0215 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/202305/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2023
Labeler - Pharmadel LLC (030129680)

Revised: 6/2023
Document Id: fe96a673-f1ee-1aa0-e053-6394a90ac3df
Set id: fc75aa2b-0e6e-e2f7-e053-6294a90ac01f
Version: 4
Effective Time: 20230620
 
Pharmadel LLC