Summit 377 Alcohol Free Foam Hand Sanitizer

Summit 377 Alcohol Free Foam Hand Sanitizer by

Drug Labeling and Warnings

Summit 377 Alcohol Free Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dyno Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMIT 377 ALCOHOL FREE FOAM HAND SANITIZER- benzalkonium chloride 0.1% soap 
Dyno Manufacturing

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 Alcohol Free Foam Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

• For hand sanitizing to decrease bacteria on the skin
• For use when soap and water are not available

Warnings

For external use only.

Do Not Use

• On children less than 2 months of age
• on open skin wounds

When using this product

Avoid contact with 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, seek medical help or contact a Poison Control Center right away

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

Supervise children under 6years of age when using this product to avoid swallowing

Inactive Ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, dihyrdroxyethyl cocamine oxide, acetamidoethoxyethanol, Citric Acid, Fragrance,

Summit 377 Alcohol Free Foam Hand Sanitizer

SUMMIT 377 ALCOHOL FREE FOAM HAND SANITIZER 
benzalkonium chloride 0.1% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79532-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.85 g  in 850 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79532-019-85	850 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2022

Labeler - Dyno Manufacturing (015718256)

Revised: 3/2022

Document Id: d9babfa4-b484-318b-e053-2a95a90aa3d5

34390-5

Set id: d9bac244-1682-5bf3-e053-2a95a90ac823

Version: 1

Effective Time: 20220308