HAND SANITIZER- benzalkonium chloride lotion

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

Buy It Now

Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Harmonia de Venezuela CA
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Benzalkonium Chloride (0.1 %)--------------------- Antimicrobial For hand sanitizing to decrease bacteria on the skin.
Authorization status:
OTC monograph not final
Authorization number:
73360-001-01, 73360-001-02

HAND SANITIZER- benzalkonium chloride lotion

Harmonia de Venezuela CA

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.

----------

Drug Facts

Active Ingredient Purpose

Benzalkonium Chloride (0.1 %)--------------------- Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin.

Warnings

For external uses only. / When using this products avoid contact of eyes. In case of eye contact,

flush eyes with water. / Stop use and ask a doctor if irritation or redness develops, or if conditions

persists for more than 72 hours. /Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Directions

Apply a small amount into palm of hands and rub hands together briskly until dry.

Inactive Ingredients

water, glycerin, stearic acid, cetostearyl alcohol, mineral oil, propylene glycol, trietanolamine,

benzophenone-3, polysorbate 60, PEG 12-

dimethicone, glyceryl stearate, fragance, imidazolidinyl urea, propyl paraben, carbomer, tocopheryl

acetate, tetrasodium EDTA, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 , FD&C

Red No. 40.

Principal display panel

HAND SANITIZER

benzalkonium chloride lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7336 0 -0 0 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

1 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

Harmonia de Venezuela CA

MINERAL O IL (UNII: T5L8 T28 FGP)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

O XYBENZO NE (UNII: 9 5OOS7VE0 Y)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

PEG-12 DIMETHICO NE ( 3 0 0 CST) (UNII: ZEL54N6 W9 5)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

IMIDUREA (UNII: M6 29 8 0 7ATL)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

EDETATE SO DIUM (UNII: MP1J8 420 LU)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7336 0 -0 0 1-0 1

4 in 1 CARTON

0 9 /20 /20 19

1

28 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:7336 0 -0 0 1-0 2

28 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /20 /20 19

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 rt333A

0 9 /20 /20 19

Labeler -

Harmonia de Venezuela CA (817307290)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Harmo nia de Venezuela CA

8 1730 729 0

ma nufa c ture (7336 0 -0 0 1)

Revised: 9/2019

Similar products

Search alerts related to this product

View documents history

Share this information