HAND SANITIZER- alcohol liquid 
Indiana Botanic Gardens

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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Hand Sanitizer

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

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

ALCOHOL ANTISEPTIC 80%


Botanic Choice

Healthy Solutions Since 1910


Topical Solution

Hand Sanitizer

Pump


Non-sterile solution


Net 2 fl oz. (60 mL)

image of label
HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10578-120-1060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
2NDC:10578-120-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
3NDC:10578-120-08240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
Labeler - Indiana Botanic Gardens (005421771)

Revised: 4/2020
Document Id: d6aa3125-035d-46cf-9619-a65df8939575
Set id: cdf6ba5b-8e3c-485f-b126-6dc739c52401
Version: 2
Effective Time: 20200429
 
Indiana Botanic Gardens