Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)
Germa Products, LLC
TOPICAL
OTC DRUG
First Aid Antiseptic As first aid to help prevent skin infection in minor cuts n scrapes n burns Warnings n For external use only You have deep or puncture wounds, animal bites or serious burns.
OTC monograph not final
GENTIAN VIOLET ANTI-INFECTIVE- GENTIAN VIOLET 1% LIQUID GERMA PRODUCTS, LLC ---------- GENTIAN VIOLET ANTISEPTIC ACTIVE INGREDIENT Gentian Violet 1% PURPOSE First Aid Antiseptic USES As first aid to help prevent skin infection in minor cuts n scrapes n burns Warnings n For external use only WARNINGS For external use only Ask a doctor before use. if you have deep or puncture wounds, animal bites or serious burns. When using this product. do not use in eyes or apply over large areas of the body. do not use longer than 1 week unless directed by a doctor. Stop use and ask a doctor if condition persists or gets worse ASK A DOCTOR BEFORE USE IF You have deep or puncture wounds, animal bites or serious burns. KEEP OUT OF REACH OF CHILDREN. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Clean the affected area, apply a small amount on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first. OTHER INFORMATION Product will stain skin and clothing. INACTIVE INGREDIENTS Ethyl alcohol 10%, and purified water. QUESTIONS OR COMMENTS 1-305-256-1464 PRINCIPAL DISPLAY PANEL Gentian Violet GENTIAN VIOLET ANTI-INFECTIVE gentian violet 1% liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:73635-1219 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 WATER (UNII: 059QF0KO0R) Germa Products, LLC ALCOHOL (UNII: 3K9958V90M) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:73635- 1219-1 29.62 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 03/29/2021 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M003 03/29/2021 LABELER - Germa Products, LLC (116 Läs hela dokumentet