Summit 367 Antibacterial Foam Soap

Summit 367 Antibacterial Foam by

Drug Labeling and Warnings

Summit 367 Antibacterial Foam by is a Otc medication manufactured, distributed, or labeled by Dyno Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMIT 367 ANTIBACTERIAL FOAM- benzalkonium chloride 0.13% 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 367 Antibacterial Foam Soap

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For hand washing to help reduce bacteria on the skin

Warnings

For external use only.

Do Not Use

In children less that 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 immediately

Directions

Pump onto dry hands
Lather vigorously for at least 15 seconds.
Rinse and dry thoroughly

Other Information

Store between 15-30C (59-86F)
Avoid Freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Cetrimonium chloride, Lauramine Oxide, Glycerin, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Tetrasodium EDTA, FD&C Red 40, FDA&C Blue 1

Summit 367 Antibacterial Foam Soap

SUMMIT 367 ANTIBACTERIAL FOAM 
benzalkonium chloride 0.13% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79532-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.105 g  in 850 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79532-015-85	850 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2021

Labeler - Dyno Manufacturing (015718256)

Revised: 4/2021

Document Id: c06c1c14-7370-5f83-e053-2995a90a2d97

34390-5

Set id: c06c4dc2-ecd3-2781-e053-2995a90af590

Version: 1

Effective Time: 20210420