HAND SANITIZER NON-ALCOHOL BASED- hand sanitizer, benzalconium liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Biorganicos Robech, S. de R.L. de C.V.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

1000ML NDC: 77733-001-01 1000 ML NDC: 77733-001-01

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER NON-ALCOHOL BASED- HAND SANITIZER, BENZALCONIUM LIQUID
BIORGANICOS ROBECH, S. DE R.L. DE C.V.
_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._
----------
EXMICROR 1L
1000ML ACTIVE INGREDIENT EXMICROR
1000ML NDC: 77733-001-01
1000 ML KEEP OUT OF REACH OF CHILDREN EXMICROR
1 1000ML NDC: 77733-001-01
1000ML PURPOSE EXMICROR
1000ML NDC: 77733-001-01
1000ML WARNINGS AND PRECAUTIONS EXMICROR
1000ML NDC: 77733-001-01
1000 ML DOSAGE AND ADMINISTRATION EXMICROR
1000ML NDC: 77733-001-01
1000ML INDICATIONS AND USAGE
1000 ML NDC: 77733-001-01
1000ML INACTIVE INGREDIENT EXMICROR
1000ML NDC: 77733-001-01
1000ML WARINIGS EXMICROR
1000ML NDC: 77733-001-01
1000 ML FULL LABEL EXMICROR
1000ML NDC: 77733-001-01
HAND SANITIZER NON-ALCOHOL BASED
hand sanitizer, benzalconium liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:77733-0 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
0 .13 g
in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
9 9 .27 mL in 10 0 mL
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
0 .36 g in 10 0 mL
GLYCERIN (UNII: PDC6 A3C0 OX)
0 .12 g in 10 0 mL
ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)
0 .12 g in 10 0 mL
Biorganicos Robech, S. de R.L. de C.V.
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:77733-0 0 1-0 2 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio
n Pro duct
10 /12/20 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
10 /12/20 20
LABELER -
Biorganicos Robech, S. de R.L. de C.V. (951577331)
REGISTRANT -
Biorganicos Robech, S. de R.L. de C.V. (951577331)
ESTA