Assured
FDA Label NDC 44019-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yinjing Medical Technology (shanghai) Co., Ltd. for the product Assured (NDC 44019-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding inactive ingredient, otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Inactive Ingredient

Inactive Ingredients:  Water

Otc - Active Ingredient

Active Ingredient

Isopropyl Alcohol 70% v/v

Otc - Purpose

Purpose

Antiseptic

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses

First aid to help prevent the risk of infection in minor cuts, scrapes and burns

For preparation of the skin prior to injection

Warnings

Warnings

For external use only

Flammable. Keep away from fire or flame

Dosage & Administration

Directions

Apply to skin as needed

Discard after single use

Otc - Do Not Use

Do not use

-in contact with eyes or with mucous membranes

-more than 7 days unless directed by a doctor

-over large areas of the body

-on deep or puncture wounds, animal bites or serious burns

Otc - Stop Use

Stop use and ask a doctor if

-excessive irritation and redness develop

-condition gets worse or persists for more than 7 days

* Please review the disclaimer below.