ELECTRONIC DEVICES DISINFECTING WIPES- isopropyl alcohol swab

Electronic Devices Disinfecting Wipes by

Drug Labeling and Warnings

Electronic Devices Disinfecting Wipes by is a Otc medication manufactured, distributed, or labeled by Generic Specialties Inc., Generic specialties Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

-

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.

STOP USE

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

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

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ELECTRONIC DEVICES DISINFECTING WIPES 
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78985-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78985-004-22	10 in 1 POUCH; Type 0: Not a Combination Product	09/30/2020
2	NDC: 78985-004-23	20 in 1 POUCH; Type 0: Not a Combination Product	09/30/2020
3	NDC: 78985-004-09	30 in 1 POUCH; Type 0: Not a Combination Product	09/30/2020
4	NDC: 78985-004-17	90 in 1 CANISTER; Type 0: Not a Combination Product	09/30/2020
5	NDC: 78985-004-21	100 in 1 CANISTER; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/30/2020

Labeler - Generic Specialties Inc. (012830710)

Registrant - Generic specialties Inc. (012830710)

Establishment
Name	Address	ID/FEI	Business Operations
Generic Specialties Inc.		012830710	manufacture(78985-004)