Summit 378 Foaming Alcohol Hand Sanitizer

Summit 378 Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

Summit 378 Foaming Alcohol 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 378 FOAMING ALCOHOL HAND SANITIZER- alcohol 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 378 Foaming Alcohol Hand Sanitizer

R.L. Williams Company

Summit 378 Foaming Alcohol Hand Sanitizer

Drug Facts

Active Ingredient(s)

Alcohol 70%

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 into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive ingredients

Water, Triethanolamine, Propylene Glycol, Carbomer, Aloe, Vitamin E.

Package Label - Principal Display Panel

SUMMIT 378 FOAMING ALCOHOL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23590-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23590-250-85	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: e354ce38-030e-71a9-e053-2a95a90a8a09

34390-5

Set id: c26379e2-a686-9ad5-e053-2a95a90aed6e

Version: 2

Effective Time: 20220708