Country: United States
Language: English
Source: NLM (National Library of Medicine)
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)
Amerrisource Bergen
GENTIAN VIOLET
GENTIAN VIOLET 10 mg in 1 mL
TOPICAL
OTC DRUG
First Aid Antiseptic First aid to help protect against infection in minor cuts, scrapes, and burns. deep or puncture wounds, serious burns, animal bites.
OTC monograph not final
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 Read the complete document