HAND SANITIZER- alcohol gel 
Alpine Industries

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.

----------

Alpine Ethyl original lavenders

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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.

Directions

Other information

Inactive ingredients

Water, Carbomer 940, Glycerin, Hydrogen Peroxide, Trolamine, Linalool, Lavender Oil (Fragrance)

Package Label - Principal Display Panel

1 gallon3785mL NDC: 79350-001-01

​3785mL NDC: 79350-001-02

purple

Single Pack2mL NDC: 78224-001-03

label60mL NDC: 78224-001-04

120mL NDC: 78224-001-05

label

label500mL NDC: 78224-001-06

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78224-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78224-001-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
2NDC:78224-001-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
3NDC:78224-001-032 mL in 1 PACKET; Type 0: Not a Combination Product06/29/2020
4NDC:78224-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
5NDC:78224-001-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
6NDC:78224-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/29/2020
Labeler - Alpine Industries (095207423)

Revised: 9/2020
Document Id: afe9e696-4886-2483-e053-2995a90a41f0
Set id: a94f6b43-fdd2-06d2-e053-2995a90a6363
Version: 3
Effective Time: 20200922
 
Alpine Industries