PURIFI HAND SANITIZER- benzalkonium chloride solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Purifi LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antimicrobial Uses Hand sanitizing to help reduce bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
80659-301-01, 80659-301-02, 80659-301-03, 80659-301-04, 80659-301-05

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PURIFI HAND SANITIZER- benzalkonium chloride solution

Purifi LLC

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.

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Purifi Moisturizing Hand Sanitizer

INSTANTLY KILLS 99.99% OF TESTED GERMS

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Hand sanitizing to help reduce bacteria on the skin

Warnings

For external use only.

When using this product avoid contact with the eyes. In case of contact, rinse eyes thoroughly with

water.

Stop use and ask a doctor if irritation or redness appears and lasts

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

immediately.

Directions

Apply liberally to hands and gently rub until dry. Reapply every 6 hours.

Other information

Store above 32°F (0°C) and below 100°F (38.8°C)

Inactive ingredients

purified water, glycerin, aloe barbadensis leaf juice

Product label

PURIFI HAND SANITIZER

benzalkonium chloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 6 59 -30 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 0 6 59 -30 1-

250 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/10 /20 20

2

NDC:8 0 6 59 -30 1-

6 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/10 /20 20

3

NDC:8 0 6 59 -30 1-

38 0 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/10 /20 20

Purifi LLC

4

NDC:8 0 6 59 -30 1-

50 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/10 /20 20

5

NDC:8 0 6 59 -30 1-

29 6 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/10 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

12/10 /20 20

Labeler -

Purifi LLC (117568842)

Revised: 12/2020

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