HAND SANITIZING AND MOISTURIZING WIPES- isopropyl alcohol swab

Hand Sanitizing and Moisturizing Wipes by

Drug Labeling and Warnings

Hand Sanitizing and Moisturizing Wipes by is a Otc medication manufactured, distributed, or labeled by Generic Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizing & moisturizing 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) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin

Sodium EDTA

PEG 40 Hydrogenated Castor Oil

Fragrance
Aqua.

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 67% v/v. Purpose: Antimicrobial, Antibacterial

Purpose

Antimicrobial, Antibacterial Hand sanitizing and moisturizing wipes

Use

Hand Sanitizing wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on injured or irritated skin
• If you are sensitive to any of its ingredients

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 at 1-800-222-1222

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

• Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Other information

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

Inactive ingredients

Aqua, Glycerin, Sodium EDTA, PEG 40 Hydrogenated Castor Oil, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZING AND MOISTURIZING WIPES 
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78985-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	67 mL  in 100

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)	0.15 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.2 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78985-002-11	60 in 1 POUCH; Type 0: Not a Combination Product	09/21/2020
2	NDC: 78985-002-18	180 in 1 CANISTER; Type 0: Not a Combination Product	09/21/2020
3	NDC: 78985-002-19	20 in 1 POUCH; Type 0: Not a Combination Product	09/21/2020
4	NDC: 78985-002-09	30 in 1 POUCH; Type 0: Not a Combination Product	09/21/2020
5	NDC: 78985-002-20	160 in 1 CANISTER; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/21/2020

Labeler - Generic Specialties, Inc. (012830710)

Registrant - Generic Specialties, Inc. (012830710)

Establishment
Name	Address	ID/FEI	Business Operations
Generic Specialties, Inc.		012830710	manufacture(78985-002)