GENTIAN VIOLET 1%- gentian violet 1% liquid 
Humco Holding Group, 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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Private Label Gentian Violet 1%

Drug facts

Active Ingredient

Gentian Violet 1%

Purpose

Antiseptic

Indications

First aid to help protect against infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

Do not apply to an ulcerative lesion as this may cause tatooing of the skin. Do not use in the eyes or over large areas of the body.

Ask a doctor before use if

redness, irritation, swelling or pain persists or increases or if infection ocurs.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

Clean the affected area and apply directly to the wound or use cotton applicator once or twice daily. Do not bandage.

Other information

will stain skin or clothing.

Inactive ingredients

Ethyl Alcohol 10% and Purified Water.

DLC 30 mL Label

DLCGV.jpgSLC Spanish

GNP Label

GNPGNP

DLC Label Arabic

DLC GV Arabic Front.jpgDLC GV Arabic Inside.jpg

DLC 59 mL Label

DLC GV 1 2floz.jpg

GENTIAN VIOLET 1% 
gentian violet 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9114
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:0395-9114-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
2NDC:0395-9114-9130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2008
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(0395-9114) , analysis(0395-9114) , pack(0395-9114) , label(0395-9114)

Revised: 12/2021
Document Id: d3d1edfc-fcd1-1889-e053-2a95a90a5d59
Set id: 60547538-9b52-8e90-e053-2991aa0ac732
Version: 5
Effective Time: 20211223
 
Humco Holding Group, Inc.