SHSNH6-3500- isopropyl alcohol solution 
Shotwell Hydrogenics, LLC

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.

----------

SHSNH6-3500 Antiseptic Topical solution HAND SANITIZER Non-Sterile Solution

Drug Facts

Active ingredients(s)

Isopropyl Alcohol 70%

​Purpose

Antiseptic

Use(s)

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 for a doctor if irritation 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

Inactive ingredients

glycerin, carbomer, deionized water, triethanolamine

Packaging

IMAGE

SHSNH6-3500 
isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73870-905
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73870-905-331249 L in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Shotwell Hydrogenics, LLC (108985732)
Establishment
NameAddressID/FEIBusiness Operations
Shotwell Hydrogenics, LLC108985732manufacture(73870-905)

Revised: 3/2020
Document Id: b7bb507c-b6f9-4785-b47a-cf6eb00d4ec5
Set id: 095b9425-2f8c-4fac-8846-ea191e4492b9
Version: 1
Effective Time: 20200328
 
Shotwell Hydrogenics, LLC