B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13%- benzalkonium chloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Midway Advanced Products LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- for handwashing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13%- BENZALKONIUM
CHLORIDE GEL
MIDWAY ADVANCED PRODUCTS 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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B4 ANTISEPTIC HAND SANITIZER ALCOHOL FREE
DRUG FACTS
_ACTIVE INGREDIENT_
Benzalkonium Chloride 0.13%
_PURPOSE_
Antiseptic
_USE_
for handwashing to decrease bacteria on the skin
_WARNINGS_
For external use only.
DO NOT USE
in the eyes
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition 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_
wet hands thoroughly with product
allow to dry without wiping
_OTHER INFORMATION_
store at room temperature
_INACTIVE INGREDIENTS_
butylene glycol, caesalpinia spinosa gum, citric acid,
ethylhexylglycerin, fragrance, glycerin,
phenoxyethanol, sodium lauryl sulfate, water
HAND SANITIZER 0.7 ML
HAND SANITIZER 100 ML
HAND SANITIZER 100 ML; 100 CT
HAND SANITIZER 1400 ML, 2000 CT
Midway Advanced Products LLC
B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13%
benzalkonium chloride gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5249 0 -50 0
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
1.3 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
GLYCERIN (UNII: PDC6 A3C0 OX)
CAESALPINIA SPINO SA RESIN (UNII: WL38 8 3U2PO)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENO XYETHANO L (UNII: HIE49 2ZZ3T)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5249 0