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El Mata Callos

El Mata Callos 0.5oz

Approved
Approval ID

21c6206e-9183-3e4f-e063-6394a90a33f7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

Vitamex USA, Corp

DUNS: 054256676

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69469-017
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (5)

CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SALICYLIC ACIDActive
Quantity: 170 mg in 1 mL
Code: O414PZ4LPZ
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/9/2024

El Mata Callos

El Mata CallosEl Mata Callos Verrugas Y Mezquinos

Wart Remover

Net Contents: 0.5 Fl. Oz. (15mL)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/9/2024

Directions

Directions:

Wash the affected area. May soak wart in warm water for 5 minutes. Dry area throughly. Gently smooth wart surface. Apply a small amount of this product to sufficiently cover each wart. Let dry. Repeat this procedure once or twice dialy as needed (until wart is removed) for up to 12 weeks. Supervise children in the use of this product,

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/9/2024

Drug Facts

Drug Facts

Active Ingredients: Purpose:

Salicylic Acid 17% Wart Remover

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/9/2024

Directions

Directions:

Wash the affected area. May soak wart in warm water for 5 minutes. Dry area throughly. Gently smooth wart surface. Apply a small amount of this product to sufficiently cover each wart. Let dry. Repeat this procedure once or twice dialy as needed (until wart is removed) for up to 12 weeks. Supervise children in the use of this product,

WARNINGS SECTION

LOINC: 34071-1Updated: 9/9/2024

Warnings

Warnings:

For External Use Only. If product gets into eyes, flush with water for 15 minutes. Avoid inhailing vapors.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/9/2024

Do not use

Do not use: on irritated skin, on any area that is infected or reddened, if you are a diabeticm or if you have poor blood circulation, on moles, birth marks, warts with hair growing from them, genital warts or muccous membranes.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/9/2024

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/9/2024

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison control center right away.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/9/2024

Other information

Other information

Store at controlled room temperature: 15-30°C (59-86°F).

Tamper Evident Feature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/9/2024

Inactive Ingredients

Inactive Ingredients: Flexible Collodion, Isopropyl Alcohol

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/9/2024

Dosage

Directions:

Wash the affected area. May soak wart in warm water for 5 minutes. Dry area throughly. Gently smooth wart surface. Apply a small amount of this product to sufficiently cover each wart. Let dry. Repeat this procedure once or twice dialy as needed (until wart is removed) for up to 12 weeks. Supervise children in the use of this product,

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El Mata Callos - FDA Drug Approval Details