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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79992-650
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL LACTATE (UNII: G5SU0BFK7O)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79992-650-01	3.78 L in 1 CONTAINER; Type 0: Not a Combination Product	08/24/2020	01/31/2024
2	NDC:79992-650-05	18.9 L in 1 CONTAINER; Type 0: Not a Combination Product	08/24/2020	01/31/2024
3	NDC:79992-650-12	1.9 L in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020	01/31/2024
4	NDC:79992-650-14	0.95 L in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2020	01/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/24/2020	01/31/2024

Labeler - Solvent Systems International (106926553)

Name	Address	ID/FEI	Business Operations
Establishment
Solvent Systems International		106926553	manufacture(79992-650)

Revised: 10/2021

Document Id: be94c234-ada4-4d85-8b4c-be4ebb4b3962

Set id: f143472e-e292-4d90-ad71-0bf6a9e2c2ea

Version: 2

Effective Time: 20211022

Solvent Systems International