HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Indiana Botanic Gardens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 80% v/v

Purpose

Antiseptic

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

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

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.

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, hydrogen peroxide, purified water USP

Questions?

1-800-644-8327

SPL UNCLASSIFIED SECTION

For your protection, this container has an outer safety seal. (Do not accept if missing or broken.)

MANUFACTURED BY: INDIANA BOTANIC GARDENS, INC. 3401 W. 37TH AVE., HOBART, IN 46342

PRINCIPAL DISPLAY PANEL

ALCOHOL ANTISEPTIC 80%

Botanic Choice

Healthy Solutions Since 1910

Topical Solution

Hand Sanitizer

Pump

Non-sterile solution

Net 2 fl oz. (60 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-120-10	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020
2	NDC: 10578-120-04	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020
3	NDC: 10578-120-08	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/29/2020

Labeler - Indiana Botanic Gardens (005421771)