Summit 362 Antibacterial Hand Soap

Summit 362 Antibacterial by

Drug Labeling and Warnings

Summit 362 Antibacterial by is a Otc medication manufactured, distributed, or labeled by R.L. Williams Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMIT 362 ANTIBACTERIAL- chloroxyenol soap 
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 362 Antibacterial Hand Soap

Drug Facts

Active Ingredients

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

Uses

• Hand wash to decrease bacteria on the skin
• Recommended for repeated use.

Warnings

• For external use only

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

Stop use

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. I swallowed, get 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 for 15 seconds.
• Rinse with potable water.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocoamide MEA, Sodium Lauryl Sulfate, Propylene Glycol, Glycol Stearate, Tetrasodium EDTA, Salt, Citric Acid, Methylchloroisothiazolinone, Methyl Isothiazolinone, Magnesium Chloride, Magnesium Nitrate

Principal Display Panel

SUMMIT 362 ANTIBACTERIAL 
chloroxyenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23590-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.03 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL STEARATE (UNII: 0324G66D0E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23590-210-85	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	part333A	01/04/2021	12/31/2021

Labeler - R.L. Williams Company (099976362)

Revised: 7/2022

Document Id: e354ed4a-44c2-0dcc-e053-2a95a90a6789

34390-5

Set id: c2627c2f-6413-f029-e053-2a95a90aff56

Version: 2

Effective Time: 20220708