ANESTAFOAM- lidocaine aerosol, foam
Onset Dermatologics 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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Temporarily relieves pain and itching due to:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
benzalkonium chloride NF, benzyl alcohol NF, isopropyl myristate NF, polysorbate 80 NF, propellant HFA-134a (1,1,1,2-tetrafluoroethane), propylene glycol USP, purified water USP
What is
ANESTAFOAM®?
ANESTAFOAM is a brand name for a
topical anesthetic foam containing a non-prescription strength lidocaine.
What is lidocaine used
for?
Lidocaine can relieve the
pain caused by minor cuts, minor burns, abrasions, sunburn, and insect
bites.
How does ANESTAFOAM
work?
Lidocaine causes a temporary
loss of feeling in the skin and surrounding tissue. ANESTAFOAM may induce a slight
cooling sensation followed by increased numbing at the site of
application.
What is in
ANESTAFOAM?
ANESTAFOAM contains a
4% concentration of lidocaine. It also contains benzalkonium chloride NF,
benzyl alcohol NF, isopropyl myristate NF, polysorbate 80 NF, propellant HFA- 134a
(1,1,1,2-tetrafluoroethane), propylene glycol USP and purified water USP. If you think
you or your child might be sensitive to any of the ingredients in ANESTAFOAM, check
with your doctor or pharmacist before using this product.
What are the directions
for use?
Shake Vigorously and Prime Before Initial Use. Shake
Vigorously Before Each Use. To Prime:
shake vigorously, then hold the ANESTAFOAM can upright, direct away from the patient,
and depress the actuator for 1 to 3 seconds or until foam begins to dispense. Apply
ANESTAFOAM to palm of hand and then apply to affected areas no more than 3 to 4 times
daily.
TO OPEN CHILD
RESISTANT CAP:
1. Hold collar with
one hand.
2. Turn cap using the other hand until the arrows on the side of the
collar and cap are aligned (><).
3. Pull the cap off the
container.
TO CLOSE AND
LOCK CHILD RESISTANT CAP:
1. Align
the arrows (><) on the side of the collar and cap and snap the cap onto
the container.
2. Hold collar with one hand and turn cap using the other hand
until the arrows on the side of the collar and cap are no longer aligned.
How do I use ANESTAFOAM
with children?
Do not apply
ANESTAFOAM to children under two years of age without consulting a physician. Although
it is not necessary to cover the area with a secondary dressing after application of
ANESTAFOAM, it is recommended when using this product on young children to prevent
accidental ingestion.
What precautions should I
take when using
ANESTAFOAM?
ANESTAFOAM causes a temporary
loss of feeling at the site of application; carefully avoid injury to the treated area
while it is numb. ANESTAFOAM should never be used internally. Do not put ANESTAFOAM in
your mouth, ears, eyes or nose. If swallowed, seek immediate medical help or contact a
Poison Control Center right away. In the event of foam contacting your eyes,
immediately wash out the eye with water, protect the eye until sensation returns, and
consult your physician. Application of ANESTAFOAM to larger areas, or more frequently
than recommended, could result in excessive absorption of lidocaine and result in
serious adverse effects.
Are there any side
effects associated with using
ANESTAFOAM?
Although uncommon, side
effects may occur and, if persistent, should be reported to your health care provider.
The most common side effects are irritation, redness, itching, and rash. If you notice
any unusual effects such as blurred vision, dizziness or drowsiness, difficulty
breathing, trembling, chest pain, or irregular heartbeat, immediately contact
a
health care professional.
How do I store
ANESTAFOAM?
Keep out of the reach
of children. Keep container closed properly when not in use. Contents under pressure.
Do not puncture or incinerate container. Store at room temperature 59º -
86º F (15º - 30º C). Do not expose to temperatures above
120º F (49º C). Dispose any unused medicine after the expiration
date.
How is ANESTAFOAM
supplied?
30g Aerosol
Can
(Child-Resistant Packaging)
NDC: 16781-126-30
30g Aerosol Can
(Non Child-Resistant Packaging)
NDC:
16781-126-32
Onset
Therapeutics
Cumberland RI
02864
888-713-8154
www.onsettx.com
Patent
Pending
P/N: 2608 Rev. 1
ANESTAFOAM
lidocaine aerosol, foam |
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Labeler - Onset Dermatologics LLC (793223707) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Onset Dermatologics LLC | 964275155 | MANUFACTURE(16781-126) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Onset Dermatologics LLC | 793223707 | MANUFACTURE(16781-126) |