GENTIAN VIOLET liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SANVALL ENTERPRISES, INC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antiseptic For external treatment of abrasions and minor cuts.

Authorization status:

OTC monograph not final

Summary of Product characteristics

GENTIAN VIOLET- GENTIAN VIOLET LIQUID
SANVALL ENTERPRISES, 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._
----------
73386-140-71
Gentian Violet
…………………….…………….……………. 0.1%
First Aid Antiseptic
For external treatment of abrasions and minor cuts.
For external use only.
Do not apply to an ulcerative lesion as this may result in tattooing
of the skin. Do not use
in the eyes.
In case of ingestion, seek medical help or contact a Poison Control
Center immediately.
Clean the affected area and apply directly to the wound or use cotton
applicator one or
twice daily. Do not bandage.
Isopropyl Alcohol, Aqua.
GENTIAN VIOLET
gentian violet liquid
PRODUCT INFORMATION
SANVALL ENTERPRISES, INC
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73386-140
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION -
UNII:3GVJ31T6YY)
GENTIAN VIOLET
0.1 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
purple
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73386-140-
71
28 g in 1 BOTTLE; Type 0: Not a Combination
Product
09/02/2021
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
09/02/2021
LABELER -
SANVALL ENTERPRISES, INC (966905507)
REGISTRANT -
CHEMCO CORPORATION (032495954)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
CHEMCO CORPORATION
032495954
manufacture(73386-140)
Revised: 6/2022