SUMMIT HAND SANITIZER- alcohol gel

Summit Hand Sanitizer by

Drug Labeling and Warnings

Summit Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by IMO SOURCE (PTY) LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient(s)

Ethyl Alcohol 70% (V/V%)

Purpose

Antiseptic

Use[s]

• To help minimize bacteria on the skin that could cause disease
• Recommended for repeated use

Warnings

For external use only

Flammable

Keep away from fire or flame

Do not use

• On children less than 2 months of age
• On open skin wounds

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water
• Avoid contact with broken skin
• Do not inhale or ingest

Stop use and ask a doctor if

irritation, rash or redness develops and persists

Keep out of reach of children

• If swallowed, seek medical help or contact a Poison Control Center immediately

Directions

• Apply enough product to cover all areas of hands 
• Rub hands together briskly until dry
• Children under 6 years of age require supervision when using this product

Other information

• Do not store above 105°F
• May cause fabric discoloration
• May harm plastics and wood finishes

Inactive Ingredients

Purified water USP, Glycerol, Hydroxyethylcellulose , Tocopheryl Acetate (Vitamin E), Benzalkonium Chloride, Tetrasodium EDTA, Citric Acid.

Package Labeling

INGREDIENTS AND APPEARANCE

SUMMIT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79190-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79190-000-01	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/30/2020

Labeler - IMO SOURCE (PTY) LTD (557388658)