SANIPOWER HAND SANITIZER- hand sanitizer gel

SANIPOWER Hand Sanitizer by

Drug Labeling and Warnings

SANIPOWER Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by IVERO d.o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Isopropyl Alcohol 15%

Ethyl Alcohol 55%

Benzalkonium chloride 0.0165%

Purpose

Antiseptic

Use

To reduce harmful bacteria on skin.

Directions For Use

• Apply 3-5mL (approx. 1 tsp) of product to dry hands and wrists and rub until dry (at least 30 seconds). Period required for biocidal effect: 30-60 seconds.
• For external use only.
• Supervise children under 6 years of age when using product to avoid swallowing.

Hazard Statements

• Causes serious eye irritation. Highly flammable liquid and vapor. May cause drowsiness or dizziness.

Precautionary Statements

• Keep out of reach of children.
• Do not use on children less than 2 months of age.
• Do not use on open skin wounds.
• If in eyes, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do; continue rinsing. If eye irritation persists, get medical advice/attention.
• Avoid breathing dust/fumes/gas/mist/vapors/aerosol.
• Keep away from heat, hot areas, sparks, open flames and other sources of ignition such as smoking.
• Store in a well-ventilated place between 15-30°C (59-86°F). Keep container tightly closed. Dispose of contents/container in accordance with national regulations.

Keep out of reach of children.

Note

Read accompanying leaflet before use. Call Poison Control if you feel unwell after use - (800) 222-1222. For additional information, see safety data sheet.

Inactive Ingredients

non-ionic surfactants, glycerin

Hazard Pictogram

Package Label - Principal Display Panel

1000mL NDC: 80133-003-10

INGREDIENTS AND APPEARANCE

SANIPOWER HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80133-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	55 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	15 mL  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0165 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80133-003-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/09/2020

Labeler - IVERO d.o.o. (499600898)