EL VALLE DECOLORIZED IODINE- alcohol tincture

El Valle Decolorized Iodine by

Drug Labeling and Warnings

El Valle Decolorized Iodine by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug facts

Active Ingredient & Purpose

Gentian Violet 1%

• Active ingredient: Purpose
• Alcohol 48% .............................: First aid antiseptic

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
• over large areas of the body

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

• do not use if clear seal over cap is missing or broken

Inactive ingredients

ammonia, iodine, sodium iodide, water

Prinicpal Display Panel

INGREDIENTS AND APPEARANCE

EL VALLE DECOLORIZED IODINE 
alcohol tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-374
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.48 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
WATER (UNII: 059QF0KO0R)
SODIUM IODIDE (UNII: F5WR8N145C)
IODINE (UNII: 9679TC07X4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-374-01	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2023	05/31/2023
2	NDC: 55758-374-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	05/31/2023

Labeler - Pharmadel LLC (030129680)