Summit 375 Gel Hand Sanitizer

Summit 375 by

Drug Labeling and Warnings

Summit 375 by is a Otc medication manufactured, distributed, or labeled by 2010 Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMIT 375- alcohol gel 
2010 Products Inc

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 375 Gel Hand Sanitizer

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Carbopol 940 (1.45% v/v).
3. Hydrogen peroxide (0.0% v/v).
4. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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

When using this product keep out of 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, get medical help or contact a Poison Control Center right away.

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, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

carbopol 940, purified water USP

Package Label - Principal Display Panel

000 mL NDC: 00000-000-00

SUMMIT 375 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81523-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)	0.14 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81523-001-01	850 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020	01/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	01/04/2021

Labeler - 2010 Products Inc (009673039)

Establishment
Name	Address	ID/FEI	Business Operations
2010 Products Inc		009673039	manufacture(81523-001)

Revised: 7/2021

Document Id: c715c58b-01a4-aff5-e053-2a95a90a2ce9

34390-5

Set id: bb1723c5-7162-d227-e053-2995a90a35e4

Version: 3

Effective Time: 20210714