Summit 377 No Rinse Hand Sanitizer

Summit 377 No Rinse Hand Sanitizer by

Drug Labeling and Warnings

Summit 377 No Rinse Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by R.L. Williams Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMIT 377 NO RINSE HAND SANITIZER- benzalkonium chloride liquid 
R.L. Williams Company

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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Summit 377 No Rinse Hand Sanitizer

R.L. Williams Company

Summit 377 No Rinse Hand Sanitizer

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin. Recommended for repeted use.

Warnings

For external use only.

When using this product

When using this product, do not use in or near the eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor

• Stop use and ask a doctor if irritation or rash appears and lasts more than 72 hours.

Keep out of reach of children

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

Directions

Directions: Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive ingredients

Water, Dihydroxypropyl Peg-5 Linoleammonium, Glycereth-2 Cocoate, Behentrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Vitamin E, and Aloe.

Package Label - Principal Display Panel

SUMMIT 377 NO RINSE HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23590-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23590-240-85	850 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/04/2021	12/31/2021

Labeler - R.L. Williams Company (099976362)

Revised: 7/2022

Document Id: e354d861-3fb2-1b7e-e053-2a95a90a21ca

34390-5

Set id: c262cb07-2d95-1696-e053-2995a90aa53d

Version: 2

Effective Time: 20220708