Electronic Devices Disinfecting Wipes
FDA Label NDC 78985-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Generic Specialties Inc. for the product Electronic Devices Disinfecting Wipes (NDC 78985-004). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(s)

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Recent Major Changes

→ Package Label - Principal Display Panel

Other

This is an Electronic Devices Disinfecting Wipes manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizing & moisturizing wipes are manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Purified water

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product

Active Ingredient(S)

Isopropyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Safe and easy way to clean electronics- Clean TVs, Phones & other Electronics.

Use

Electronic Devices Disinfecting Wipes to clean and help reduce bacteria that potentially cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 at 1-800-222-1222

Directions

Open the resealable label and pull wipe.Wipe the area. Wipe thoroughly all parts of area you want to clean, repeat as needed. No need to rinse with water. Dispose of wipe in trash after use. Do not flush. Always close the resealble label after use to avoid moisture loss.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Purified water

Recent Major Changes

Electronic Devices Disinfecting Wipes to clean and help reduce bacteria that potentially can cause disease.

* Please review the disclaimer below.

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