Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)
Humco Holding Group, Inc.
TOPICAL
OTC DRUG
Antiseptic First aid to help protect against infection in minor cuts, scrapes, and burns. redness, irritation, swelling or pain persists or increases or if infection ocurs.
OTC monograph not final
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._ ---------- 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 GNP LABEL DLC LABEL ARABIC DLC 59 ML LABEL GENTIAN VIOLET 1% gentian violet 1% liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:0395-9114 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 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:0395- 9114-92 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 2 NDC:0395- 9114-91 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 MARKETING INFORMATION Humco Holding Group, Inc. MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monog Прочетете целия документ