GNP GENTIAN VIOLET 1%- gentian violet 1% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)

Available from:

Amerrisource Bergen

INN (International Name):

GENTIAN VIOLET

Composition:

GENTIAN VIOLET 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antiseptic First aid to help protect against infection in minor cuts, scrapes, and burns. deep or puncture wounds, serious burns, animal bites.

Authorization status:

OTC monograph not final

Summary of Product characteristics

                                GNP GENTIAN VIOLET 1%- GENTIAN VIOLET 1% LIQUID
AMERRISOURCE BERGEN
----------
GNP GENTIAN VIOLET 1%
Drug facts
ACTIVE INGREDIENT
Gentian Violet 1%
PURPOSE
First Aid Antiseptic
USES
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 YOU HAVE
deep or puncture wounds, serious burns, animal bites.
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.
LABEL
GNP GENTIAN VIOLET 1%
gentian violet 1% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:24385-003
ROUTE OF ADMINISTRATION
TOPICAL
Amerrisource Bergen
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION -
UNII:3GVJ31T6YY)
GENTIAN VIOLET
10 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:24385-
003-46
59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
11/02/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
01/01/2008
LABELER -
Amerrisource Bergen (007914906)
REGISTRANT -
Pharma Nobis, LLC (118564114)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Pharma Nobis,
LLC
118564114
manufacture(24385-003) , analysis(24385-003) , pack(24385-003) ,
label(24385-003)
Revised: 12/2023
                                
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