HANDS FIRST TM- benzalkonium chloride spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hands First, LLC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antimicrobial - For handwashing to decrease bacteria on the skin - For temporary protection of minor cuts, scrapes, burns and chapped or cracked skin - symptoms worsen, last for more than seven days, or new symptoms occur at any time

Authorization status:

OTC monograph not final

Summary of Product characteristics

HANDS FIRST TM- BENZALKONIUM CHLORIDE SPRAY
HANDS FIRST, 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._
----------
_DRUG FACTS_
_ACTIVE INGREDIENT_
Benzalkonium Chloride 0.13%
_PURPOSE_
Antimicrobial
_USE_
For handwashing to decrease bacteria on the skin
For temporary protection of minor cuts, scrapes, burns and chapped or
cracked skin
_WARNINGS_
For external use only.
Keep out of the reach of children. If swallowed, get medical help, or
contact a Poison
Control Center right away.
Do not use in the eyes.
Do not use on deep or puncture wounds, animal bites or serious burns.
Extended use may increase risk of sunburn.
STOP USE AND ASK A DOCTOR IF:
symptoms worsen, last for more than seven days, or new symptoms occur
at any
time
_DIRECTION_
Uses as needed.
Remove cap and pump foam into palm of hands.
Rub foam onto hands.
Allow to air dry.
_OTHER INFORMATION_
save carton for full directions and warnings
store between 20 to 25 C (68 to 77 F)
o
o
_INACTIVE INGREDIENTS_
water, cocamidopropyl betaine , allantoin, glycolic acid, dimethicone,
aloe vera leaf,
lavender extract, colloidal silver, tetrasodium EDTA, phenoxyethanol,
ethylhexyl
glycerine.
_QUESTIONS?_
Call 1-800-603-0589 between 9am and 5pm (EST) Monday through Friday or
visit
www.handsfirst.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Hands First
4 in 1 action
Alcohol Free Spray
Hand Sanitizer
Doctor created and hospital tested
Sanitize anytime, anywhere
Temporarily protect minor cuts and scrapes
Hydrate your skin
Clean without water
Kills 99.99% of germs
4 fl oz (118mL)
HANDS FIRST TM
benzalkonium chloride spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81858-042
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
1.3 mg
i