Summit 378 Foam Instant Hand Sanitizer-Alcohol

Summit 378 Foam Instant Hand Sanitizer by

Drug Labeling and Warnings

Summit 378 Foam Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dyno Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMIT 378 FOAM INSTANT HAND SANITIZER- ethyl alcohol 70% liquid 
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 378 Foam Instant Hand Sanitizer-Alcohol

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antibacterial

Uses

Hand Sanitizer to help reduce bacteria on the skin 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

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

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

Water, isopropyl myristate, meadowfoamamidolpropyl betaine, fragrance, T-Butyl Alcohol, PEG10 dimethicone, tocopheryl acetate, Denatonium Benzoate

Summit 378 Foam Instant Hand Sanitizer-Alcohol

SUMMIT 378 FOAM INSTANT HAND SANITIZER 
ethyl alcohol 70% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79532-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	595 mL  in 850 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79532-016-85	850 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2021

Labeler - Dyno Manufacturing (015718256)

Registrant - Dyno Manufacturing (015718256)

Revised: 7/2021

Document Id: c7a4335a-2385-d4e6-e053-2995a90a9bff

34390-5

Set id: c7a4335a-2384-d4e6-e053-2995a90a9bff

Version: 1

Effective Time: 20210721