ELECTRONIC DEVICES DISINFECTING WIPES- isopropyl alcohol swab 
Generic Specialties Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 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 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 at 1-800-222-1222

Directions

Other information

Inactive ingredients

Purified water

Package Label - Principal Display Panel

90100102030

ELECTRONIC DEVICES DISINFECTING WIPES 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78985-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78985-004-2210 in 1 POUCH; Type 0: Not a Combination Product09/30/2020
2NDC:78985-004-2320 in 1 POUCH; Type 0: Not a Combination Product09/30/2020
3NDC:78985-004-0930 in 1 POUCH; Type 0: Not a Combination Product09/30/2020
4NDC:78985-004-1790 in 1 CANISTER; Type 0: Not a Combination Product09/30/2020
5NDC:78985-004-21100 in 1 CANISTER; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/30/2020
Labeler - Generic Specialties Inc. (012830710)
Registrant - Generic specialties Inc. (012830710)
Establishment
NameAddressID/FEIBusiness Operations
Generic Specialties Inc.012830710manufacture(78985-004)

Revised: 9/2020
Document Id: b05e743d-7a8a-eea6-e053-2995a90a2b29
Set id: b05e7bf8-f290-2851-e053-2995a90ad8c0
Version: 1
Effective Time: 20200928
 
Generic Specialties Inc.