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

labellabel

SUMMIT 367 ANTIBACTERIAL FOAM 
benzalkonium chloride 0.13% soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79532-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.105 g  in 850 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79532-015-85850 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2021
Labeler - Dyno Manufacturing (015718256)

Revised: 4/2021
 

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