ANESTAFOAM - lidocaine aerosol, foam 
Onset Therapeutics, LLC

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Anestafoam
(LIDOCAINE 4%) TOPICAL ANESTHETIC FOAM

Drug Facts

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses:

Temporarily relieves pain and itching due to:

Warnings

OTC - WHEN USING

For External Use Only

OTC - DO NOT USE

OTC - STOP USE

Stop use and ask a doctor if:

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive ingredients

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

Anestafoam PI

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

Anestafoam Logo


Onset Logo

Onset Therapeutics
Cumberland RI 02864
888-713-8154
www.onsettx.com


Patent Pending
P/N: 2608 Rev. 1

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Anestafoam Outer Carton Child Resistant - 30g

NDC 16781-126-30

Anestafoam®
(Lidocaine 4%)
Topical Anesthetic Foam

Pain Relief Foam

Net Weight 30g

Anestafoam Outer Carton Child Resistant - 30g


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Anestafoam Inner Label Child Resistant - 30g

Anestafoam®
(Lidocaine 4%)
Topical Anesthetic Foam

NDC 16781-126-30 Net Weight 30g

Anestafoam Inner Label Child Resistant - 30g



ANESTAFOAM 
lidocaine   aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)16781-126
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
POLYSORBATE 80 
ISOPROPYL MYRISTATE 
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
116781-126-301 CAN In 1 BOXcontains a CAN
130 g In 1 CANThis package is contained within the BOX (16781-126-30)
216781-126-321 CAN In 1 BOXcontains a CAN
230 g In 1 CANThis package is contained within the BOX (16781-126-32)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/20/2008

Labeler - Onset Therapeutics, LLC (793223707)
Registrant - Collegium Pharmaceutical, Inc. (032531241)
Establishment
NameAddressID/FEIOperations
Onset Therapeutics, LLC793223707RELABEL
Establishment
NameAddressID/FEIOperations
Collegium Pharmaceutical, Inc.032531241MANUFACTURE
Revised: 12/2009Onset Therapeutics, LLC