El Valle Decolorized Iodine (alcohol 48%)(da)

SPL v4

SPL

SPL Set ID fd7a227b-536c-b3f7-e053-6394a90a4158

Route

TOPICAL

Published

Effective Date 2023-05-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.48 mg)

Inactive Ingredients

Ammonia Water Sodium Iodide Iodine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2023-05-31 Until 2027-08-01

Description

Drug facts

Purpose

Gentian Violet 1%

Medication Information

Purpose

Gentian Violet 1%

Description

Drug facts

Uses

First aid to help prevent infection in

minor cuts
scrapes
burns

Section 55105-1

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

Warnings

FOR EXTERNAL USE ONLY.

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

Do Not Use

longer than 1 week, unless directed by a doctor
in the eyes
over large areas of the body

Drug Facts

Drug facts

Other Information

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

Inactive Ingredients

ammonia, iodine, sodium iodide, water

Prinicpal Display Panel

Active Ingredient & Purpose

Gentian Violet 1%

Keep Out of Reach of Children.

If swallowed, get medical help, or contact a Poison Control Center immediately.

Stop Use and Consult A Doctor If

conditions persist or gets worse

Ask A Doctor Before Use If You Have

a deep or puncture wounds
serious burns
animal bites

Structured Label Content

Uses

First aid to help prevent infection in

minor cuts
scrapes
burns

Section 55105-1 (55105-1)

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

Warnings

FOR EXTERNAL USE ONLY.

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

Do Not Use (Do not use)

longer than 1 week, unless directed by a doctor
in the eyes
over large areas of the body

Drug Facts

Drug facts

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

ammonia, iodine, sodium iodide, water

Prinicpal Display Panel

Active Ingredient & Purpose

Gentian Violet 1%

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help, or contact a Poison Control Center immediately.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

conditions persist or gets worse

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a deep or puncture wounds
serious burns
animal bites

Advanced Ingredient Data

[{"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.48", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM IODIDE", "unii": "F5WR8N145C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help prevent infection in minor cuts scrapes burns", "55105-1": "Active ingredient Purpose Alcohol 48% ............................. First aid antiseptic", "Warnings": "FOR EXTERNAL USE ONLY.", "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", "Do not use": "longer than 1 week, unless directed by a doctor in the eyes over large areas of the body", "Drug Facts": "Drug facts", "Other information": "do not use if clear seal over cap is missing or broken", "Inactive ingredients": "ammonia, iodine, sodium iodide, water", "Active Ingredient & Purpose": "Gentian Violet 1%", "Keep out of reach of children.": "If swallowed, get medical help, or contact a Poison Control Center immediately.", "Stop use and consult a doctor if": "conditions persist or gets worse", "Ask a doctor before use if you have": "a deep or puncture wounds serious burns animal bites"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.110494 · Updated: 2026-03-14T23:11:00.469021