SPL v1
SPL
SPL Set ID b201e406-05f4-9b96-e053-2a95a90ac835
Route
TOPICAL
Published
Effective Date 2020-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (13 g)
Inactive Ingredients
Aloe Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-12

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

Warnings: For external use only

Flammable: Keep away from heat and flame

Indications and Usage

Uses

  • To decrease bacteria on the skin that could cause disease
  • Recommended for repeated use
Dosage and Administration
  • Wet hands thoroughly with product and allow to dry without wiping
  • Not recommended for infants
Description

Benzalkonium Chloride 0.13%

Section 42229-5

DERMATOLOGIST TESTED

PARABEN FREE

SOOTHING ALOE VERA

KILL 99.9% OF GERMS

ALCOHOL FREE

60 SOFT WIPES

TO OPEN PACKAGE

Flip open dispensing cap

Locate wipe at center of rolland thread through small opening in lid

For best results dispense wipes at angle

When finished, snap lid acap shut to retain moisture

For use at home, at work, ro on-the-go.

DO NOT USE BEFORE AND AFTER EATING

Feature & details:

• Helps reduce the risk of infections

• Leaves no stickiness or residue on hands

• Removes light soils and dirt from hands

Manufactured by Shandong Fengrui Biotechnology Co., Ltd.

Manufactured in No.168, Qingwei Road, Dongliuting Community, Liuting sub-district, Qingdao, CHN

DO NOT FLUSH

NDC 80832-001-01

Section 44425-7

Other information

  • Do not store above 105°F
  • May discolor some fabrics harmful to wood finishes and plastics
Section 50565-1

If swallowed, get medical help or contact a poison control center right away

Section 50566-9

Stop use and ask a doctor

  • if irritation or redness develops
  • Condition persists for more than 72 hours
Section 50567-7

Keep out of eyes

In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Section 51727-6

Aloe leaf juice 0.3%, water(aqua)

Section 51945-4

NDC 80832-001-01

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • To decrease bacteria on the skin that could cause disease
  • Recommended for repeated use
Dosage and Administration (34068-7)
  • Wet hands thoroughly with product and allow to dry without wiping
  • Not recommended for infants
Warnings and Precautions (34071-1)

Warnings: For external use only

Flammable: Keep away from heat and flame

Section 42229-5 (42229-5)

DERMATOLOGIST TESTED

PARABEN FREE

SOOTHING ALOE VERA

KILL 99.9% OF GERMS

ALCOHOL FREE

60 SOFT WIPES

TO OPEN PACKAGE

Flip open dispensing cap

Locate wipe at center of rolland thread through small opening in lid

For best results dispense wipes at angle

When finished, snap lid acap shut to retain moisture

For use at home, at work, ro on-the-go.

DO NOT USE BEFORE AND AFTER EATING

Feature & details:

• Helps reduce the risk of infections

• Leaves no stickiness or residue on hands

• Removes light soils and dirt from hands

Manufactured by Shandong Fengrui Biotechnology Co., Ltd.

Manufactured in No.168, Qingwei Road, Dongliuting Community, Liuting sub-district, Qingdao, CHN

DO NOT FLUSH

NDC 80832-001-01

Section 44425-7 (44425-7)

Other information

  • Do not store above 105°F
  • May discolor some fabrics harmful to wood finishes and plastics
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if irritation or redness develops
  • Condition persists for more than 72 hours
Section 50567-7 (50567-7)

Keep out of eyes

In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Section 51727-6 (51727-6)

Aloe leaf juice 0.3%, water(aqua)

Section 51945-4 (51945-4)

NDC 80832-001-01

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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