g
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I. PRODUCTIDENTIFICATION
r:
TbsdeNams e,fp'gflfJuptc*l Gel
Dermik
Laboratories,
Inc.
1050Westlakes
Drive
Berwyn,?A 19312-2421
24-Hour (800)424-9300
EmergencyPhone:
2. COMPOSNION/ INFORMATION ON INGRENENTS
CommonName CASNo. Exposure
Limits
6.66Vo
Benzoyl Peroxide :
Gel
Water NE NE
Benzoyl Peroxide 94360 NE
Cartomer NF (Carbopol NF)
934, 934, 9m3014 ACGIHTLVI$t0ppm
Sodium Hydroxide t3tw32 ACCIHTLV* 2rngm3
DioctylSodium Sulfosuccinate 571117 NE
ClindamycinPhosphate 24729-96-2 NE
NE = Nor Established
3. HAZ ARDSIDENTIFICATION
Emergency overview R36 Irritatingto eyes.R22 Harmful swallowetl.
if R43 May cause
sensitization skin contact.please
by see
section if involved a fire.
5 in
Eye R36 lritating to eyes.
skin contact R43 May cause
sensitization skincontact.
by Thisprocluct intended dermal butmaycause
is for use localirritationor
hypersensitivity
reactions.
skin AbsorptionThismaterial readilysoluble water.Absorption
is in though intactor abraded is possible.
the skin
IngestionR22 Harmfulif swallowed.
InhalationNot a likely routeof exposure.
chronic Effects/
carcinogenicifyAdverse
potential
reactions detailed section l, thepackage
are in insert, physician,s
I the Desk
Reference Exhapharmacopoeia.
and/ortheMartindale
4.FIR.STAIDMEASURDS
In case contact
of witlt,eyes,
rinseimmediately
with plentyof waterandseekmedical
advice.(526)
3*
skin After contact
with skin,washimmecliately plentyof water.(s2g) Seekmedical
with attention if symptomsappear.
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I
BenzaClin
TopicalGel
If swallowed,
seekmedical
adviceimmediately showthiscontainer label. (546)
and or
]sestion
Inhalation Not an expectedroute of exposurein this closageform.
Note to Physician No systemic toxicity has beenreportedfrom human exposureto benzoyl peroxide. The primary
effests are irritation
to nose,throat' eyesand skin' Skin contactwith benzoylperoxidehasbeenreportedto causeprimary
and sensitization clermatitis.
Moderate erythema and edema have followed topical exposureto l0%osolutions. For inadvertantingestion,
immediate dilution with
milk or water is recommended due to initant effects. Immediately dilute with 4 to 8 ounces(120 to 240 mL)of milk or warer(not ro
exceed15 ml/kg in a child). Though inhalation is not a likely route of exposwe, move patient to fresh air. Monitor for respiratory
distress. If cough or difficulty in breathing develops,evaluatefor respiratory tract irritation, bronchitis, or pneumonitis. Administer 100
percsnt humidified supplementaloxygen with assistedventilation as required. Patientstaking clindamycin have developeddizziness,
nausea' vomitingocolitis, with diarrhea,abdominalpain, fever and blood or mucousin stools,skin rashes, proctitis and vaginitis and
other reactions,which are uncommon, including exudativeerythemamultiforme, reversibleelevationof SGOT & SGPT"
granulocytopenia, thrombocytopenia and anaphylactoid reactions.
5. FIRE FIGTITING MEA.SI.]RES
General Hazards Toxic gasesand vapors (such as benzoic acid smoke and carbon monoxide) may be releascdin a fire involving
benzoyl peroxide. Risk of explosion by shock,friction, fire or other sourcesof ignition. (R2) If material on t'ire or involved in fire: use
water in flooding quantities as fog. Solid streamsof water may be ineffective. Cool all affected containerswith fiooding quantities of
water. Apply water from as far a distanceas possible.Use "alcohol" fbam, dry chemical or carbon dioxide dangerouslyexplosive.
Evacuation: the materialis on fire or involvedin fire consider
If evacuation one-halfmile radius.
of
Fire Fighting ExtinguishingMedia For benzoyl peroxide: If material on fire or involved in fire: usewater in flooding quantitiesas fog.
strealnsof water may be ineffective. Cool all affectedcontainerswith flooding quantitiesof water. Apply water from as far a
1}tiO
Jistance as possible.Use "alcohol" foam, dry chemicalor carbondioxide dangerously explosive.
Fire Fighting Instructions Keep personnelremoved from and upwind of fire. Wear full firefighting turn-out gear (full bunker gear) and
self-containedbreathing apparatus(SCBA). Evacuation:If the material is on fire or involved in fire consider evacuationof one-half mile
radius,
Hazardous Combustion Products Toxic gasesand vapors (such as benzoic acid smoke and carbon monoxide) may be releasedin a fire
involving benzoylperoxide.
6. ACCINENTAL REI.EASE MEASURES
Large Spill 536 Wear suitableprotectiveclothing. S16 Keep away from sources ignition - No smoking. Scoopgel into suitable
of
containerfor disposal. Mop areathoroughly.
Small Spill 536 Wear suitable protective clothing. Sl6 Keep away from sourcesof ignition - No smoking. Scoop gel into suitable
containerfor disposal. Wipe areawith papertowels moistened with water/detergent.
7. HANDLING AND STORAGE
Special Handling Protect packagefrom physical damage.Wash thoroughly after handling.
-
Special
StorageSl6 Keepawayfromsources ignition No smoking.
of
EyeProtectionClean-up,
manufacturing packaging requiresafetyglasses goggles.
operations
and or
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BenzaClin Topical Gel
-Skin or
protection recommended spill clean-up
protection AnsellEdmontSOLVEX@ gloves equalor grcater for
are
of
or
potential handexposure.
for
with a
operations
manufacturing/packaging
uponpotential
protectionbased
operations requirerespiratory
protection Clean-up,
manufacturing packaging may
and
Respiratory
exposures individualingredients.
to
shouldbedesigned asto offer no significantexposure this
to
so
Controls Manufacturing packaging
operations
and
Engineering
material.
9. PHYSICALAND CHEMICAL PROPERTMS
Gel
Appearance:
25"CQ7.o F) (BenzoYl Peroxide)
Gravity:
Specific
103- 106 "C QI7 .4 - 222.8" F) (Benzoyl Peroxide)
Melting Point:
242.24 (B enzoylPeroxide)
Weight:
Molecular
I
IO.STABILITY AND REACTIVTTY
ethers'
amines,
etc.),acids,alkalis'alcohols,
(wood,paper,
substances
Combustible
Incompatibitify BenzoylPeroxirle:
For
may be released a
in
monoxide)
acidsmoke carbon
and
products Toxic gases vapors(suchasbenzoic
and
Decomposition
Hazardous
peroxide.
benzoyl
_ fire involving
polymerization not beenreported occurundernormaltemperatures pressures'
and
to
u{azardous polymerizationHazardous has
11.TOXICOLOCICAL INFORMATION
throat,
peroxide.Theprimaryeffectsareirritationto nose,
exposure benzoyl
to
from human
toxicity hasbeenreportecl
No systemic
erythema
Moderate
dermatitis.
primaryandsensitization
eyesandskin. Skin contactwithbenzoylperoxide beenreported causeto
has
nausea,
dizziness,
takingclindamycin developed
have
havefollowedtopicalexposure l0% solutions. Patients
to
andedema
proctitisandvaginitis andother
skin rashes,
pain,feverandbloodor mucous stools,
in
abdominal
vomiting,colitis,with dianhea,
granulocytopenia,
elevation scor & SGPT,
of
reversible
multiforme,
erythema
includingexudative
whichareuncommon,
reactions.
reactions'
thrombocytopenia anaphylactoid
and
t 2.ECOLOGICAL INFORMATION
environmenlal or toxicity is available thistime'
at
fate
No information determination rmusual
of
for
CONSIDERATIONS
13.DISPOSAL
is
regulations.Incineration
stateandlocalenvironmental
Information wastemustbe disposed in accordance federal,
with
of
Disposal
thepreferredmethod
Page of4
3
BenzaClin
TopicalGel
DOT:
ProperShippingName: Not Regulated
IATA:
ProperShippingName: Not Regulated
Transportation Hazardous
of MaterialDescriptionDomestic
DOT Label:Not Regulated;
International
(IMO) label:Drugs/lrrfedicines
SeecurrentDOT or IATA shippingregulations.
15.REGUI.-{TORYINFORMATION
TSCAInventoryStatus: This productis a pharmaceutical
agentandassuchis regulated theUnited States
FoodandDrug
by
(FDA).
Administration
16.OTHERINFORMATION
Other Information Theinformationcontainedhereinis based
upondataconsidered andaccurate.
true DermikLaboratories makes no
warranties,express implied,asto theadequacy the information herein.Thisinformationis offeredsolelyfor the user's
or of contained
consideration,
investigation verification.Reportto themanufacturer allegations healtheffectsresultingfrom handlingor
and any of
accidentalcontact
with thismaterial.
version,
10ffi,
fri9inal
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