EL VALLE GENTIAN VIOLET- gentian violet 1% 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:

Pharmadel LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Gentian Violet 1% First aid to help prevent infection in - minor cuts - scrapes - burns

Authorization status:

OTC monograph not final

Summary of Product characteristics

EL VALLE GENTIAN VIOLET- GENTIAN VIOLET 1% LIQUID
PHARMADEL LLC
_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._
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EL VALLE GENTIAN VIOLET 1%
_DRUG FACTS_
Drug facts
_ACTIVE INGREDIENT & PURPOSE_
Gentian Violet 1%
_ACTIVE INGREDIENT_
_PURPOSE_
Gentian Violet 1% .............................
First aid antespetic
_USES_
First aid to help prevent infection in
minor cuts
scrapes
burns
_WARNINGS_
FOR EXTERNAL USE ONLY.
DO NOT USE
longer than 1 week, unless directed by a doctor
in the eyes
ASK A DOCTOR BEFORE USE IF YOU HAVE
a deep or puncture wounds
serious burns
animal bites
STOP USE AND CONSULT A DOCTOR IF
conditions persist or gets worse
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help, or contact a Poison Control Center
immediately.
_DIRECTIONS_
clean the affected area
apply a small amount directly to the affected area 1 to 3 times a day
may cover area with sterile bandage
_OTHER INFORMATION_
product will stain clothing and skin
do not use if clear seal over cap is missing or broken
_INACTIVE INGREDIENTS_
alcohol, water
_PRINCIPAL DISPLAY PANEL_
EL VALLE GENTIAN VIOLET
gentian violet 1% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55758-373
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
BASIS OF
Pharmadel LLC
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:55758-
373-01
30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
05/31/2023
2
NDC:55758-
373-02
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
05/31/2023
05/31/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR