PURIDENE HAND SANITIZER- alcohol gel

Puridene Hand Sanitizer by

Drug Labeling and Warnings

Puridene 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, Acrylate Copolymer, Glycerol, Triethanolamine, Tocopheryl Acetate, Tetrasodium EDTA

Package Labeling: 500ml

Package Labeling: 3780ml

Package Labeling: 1000ml

Package Labeling: 100ml

Package Labeling: 30ml

Package Labeling: 300ml

Package Labeling: 5000ml

Package Labeling: 50ml

INGREDIENTS AND APPEARANCE

PURIDENE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79190-001
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)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79190-001-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
2	NDC: 79190-001-02	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
3	NDC: 79190-001-03	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
4	NDC: 79190-001-04	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
5	NDC: 79190-001-05	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
6	NDC: 79190-001-06	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
7	NDC: 79190-001-07	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
8	NDC: 79190-001-08	50 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)