ANTISEPTIC HAND SANITIZER

ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Solvent Systems International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND SANITIZER- alcohol gel 
Solvent Systems International

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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ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin
recommended for repeated use
for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use
in children less than 2 months of age
on open skin wounds

When using this product
do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if
irritation and redness develop
condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)
avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

carbomer, fragrance, glycerin, lauryl lactate, polyethylene glycol, water

Questions? +1-847-437-1100

You may also report serious side effects to this phone number.
Mon - Fri 9:00 am - 5:00 pm

Alcohol Gel

Manufactured by

Solvent Systems International
70 King Street, Elk Grove Village, IL 60007

www.solvent-systems.com

Made in the USA

Packaging

Alcohol65

ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79992-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79992-650-013.78 L in 1 CONTAINER; Type 0: Not a Combination Product08/24/202001/31/2024
2NDC: 79992-650-0518.9 L in 1 CONTAINER; Type 0: Not a Combination Product08/24/202001/31/2024
3NDC: 79992-650-121.9 L in 1 BOTTLE; Type 0: Not a Combination Product08/24/202001/31/2024
4NDC: 79992-650-140.95 L in 1 BOTTLE; Type 0: Not a Combination Product08/24/202001/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/24/202001/31/2024
Labeler - Solvent Systems International (106926553)
Establishment
NameAddressID/FEIBusiness Operations
Solvent Systems International106926553manufacture(79992-650)

Revised: 10/2021