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:

Antiseptic 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
REFERENCE LABEL SET ID: F39D7373-1742-49CC-986C-9BB95955B847
_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 BENZALKONIUM CHLORIDE GEL 0.13%
ACTIVE INGREDIENT
Benzalkonium chloride 0.13%
PURPOS E
Antiseptic
US E
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
if condition persists for more than 72 hours.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact Poison Control Center right
away.
DIRECTIONS
Wet hands thoroughly with product and allow to dry without wiping
OTHER INFORMATION
store at room temperature
INACTIVE INGREDIENTS
butylene glycol, caesalpinia spinosa gum, citric acid,
ethylhexylgycerin, fragrance, glycerin,
phenoxyethanol, sodium lauryl sulfate, water
PACKAGE LABELING:
B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13%
benzalkonium chloride gel
Midway Advanced Products LLC
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)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
PHENO XYETHANO L (UNII: HIE49 2ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE MARKETING END DATE
1
NDC:5249 0 -50 0 -15
15 mL in 1 TUBE;