GENERIC -HAND SANITIZER- generic specialties gel

Generic -Hand Sanitizer by

Drug Labeling and Warnings

Generic -Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Generic Specialties, Inc., Generic Secialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer 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 sanitizer is 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 (ethanol) (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.
Triethanolamine
Vitamin E
Aloevera extract
Acrylate crosspolymer
Fragrance
Sterile distilled water or boiled cold 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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, anti-microbial, Hand Sanitizer

See details in the labels attached below....

Use

Hand Sanitizer 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 open skin wounds

when using this product

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

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
• As referenced on the product labels.

Other information

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

Inactive ingredients

Acrylate Crosspolymer, Triethanolamine, Vitamin E, Alovera extract, Ethyl Alcohol, Fragrance, Water

Package Label - Principal Display Panel

package label principal display panel

As mentioned below NDC codes

50 ml - 78985-001-01

89 ml - 78985-001-02

100 ml - 78985-001-03

200 ml - 78985-001-04

350 ml - 78985-001-08

500 ml - 78985-001-05

1000 ml - 78985-001-06

5000 ml - 78985-001-07

INGREDIENTS AND APPEARANCE

GENERIC -HAND SANITIZER 
generic specialties gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78985-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.2 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.6 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78985-001-03	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
2	NDC: 78985-001-04	200 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
3	NDC: 78985-001-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
4	NDC: 78985-001-06	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
5	NDC: 78985-001-02	89 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
6	NDC: 78985-001-07	5000 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
7	NDC: 78985-001-08	350 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
8	NDC: 78985-001-01	50 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - Generic Specialties, Inc. (012830710)

Registrant - Generic Specialties, Inc. (012830710)

Establishment
Name	Address	ID/FEI	Business Operations
Generic Secialties, Inc.		012830710	manufacture(78985-001)