U HAND SANITIZER CLASSIC: Package Insert and Label Information

U HAND SANITIZER CLASSIC- benzalkonium chloride solution
BLUE SEA AEROSOL & DAILY CARE CO., LTD

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.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

For Hand Sanitizing

Warnings

For external use only — Hands

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 skin irritation develops

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

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U HAND SANITIZER CLASSIC
benzalkonium chloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72119-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72119-004-01 100 mL in 1 BOTTLE None
2 NDC:72119-004-02 200 mL in 1 BOTTLE None
3 NDC:72119-004-03 473 mL in 1 BOTTLE None
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 Operations
BLUE SEA AEROSOL & DAILY CARE CO., LTD 544373091 manufacture (72119-004)

Revised: 06/2020 BLUE SEA AEROSOL & DAILY CARE CO., LTD

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