U HAND SANITIZER CLASSIC- benzalkonium chloride solution

U HAND SANITIZER CLASSIC by

Drug Labeling and Warnings

U HAND SANITIZER CLASSIC by is a Otc medication manufactured, distributed, or labeled by BLUE SEA AEROSOL & DAILY CARE CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

For Hand Sanitizing

Warnings

For external use only - Hands

WHEN USING

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

Stop use and ask a doctor if skin irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and rub until dry without wiping
• For children under 6, use only under adult supervision
• Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Sorbitol, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

U HAND SANITIZER CLASSIC 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72119-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72119-004-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
2	NDC: 72119-004-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
3	NDC: 72119-004-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/19/2020

Labeler - BLUE SEA AEROSOL & DAILY CARE CO., LTD (544373091)

Establishment
Name	Address	ID/FEI	Business Operations
BLUE SEA AEROSOL & DAILY CARE CO., LTD		544373091	manufacture(72119-004)