Label: GENTIAN VIOLET TOPICAL SOLUTION- gentian violet liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 65055-401-01, 65055-401-02 - Packager: Laboratorios Jaloma, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 27, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENTIAN VIOLET TOPICAL SOLUTION
gentian violet liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65055-401 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 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65055-401-01 25 mL in 1 BOTTLE, PLASTIC 2 NDC:65055-401-02 40 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/27/2013 Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357) Establishment Name Address ID/FEI Business Operations Laboratorios Jaloma, S.A. de C.V. 811122357 manufacture(65055-401)
