T QM 

IConsumer Product9 

Gornpany fncorporated 

12 Spiglman Road 

 Fairiield, New Jersey fli Op4 

(201) 808-7111 

FAK: (201) 808-7234 

FiNA,L REPORT 

CLTENT: 

ATTENTTON: 

lnformatifln Scrvices Nlanager 

TEST: Repeateel Tnsuit Patch Test 

TEST MATSRIAL: 

EXPER[MiENT 

RERERENCE NU1tiY6ER; 

Geral N. Wachs, h4.D., F.A C.P. 

Mi;dicxl DirCtitor 

-~ 

7oY r li N 

Ex utive Vice Presidenl 

Cliaical Evalualiotls z 

/f 

~G•~irc~~~t 1C `lr

;

•~=t 

I3awn M. Serkcnhush, H.S 

Quality Assurance Unit 

oate Acr,$ust 17 1943 . 

.TFhe 

7hlsreport fSsuL*miNOtl PGr thn exdusfveuse pf tho paraon, par:nershlp, orcorppra!ipn to whom it is addrassed, entl nNthqr {ti9report nor 1hB 

rnreme ol ihese LaGOratortes nur oi eny mpmbor ot h's statt, rnay bB u5etl im mnnection with 4he advertlsinH or saie o# anY product or pracess 

wimoutwrltt9n suthurizrtion. 
T1tC ubjactive of the Qivality As.surance Unit (QAU) is [o mottitor the conduct and mporting of 

clinical laboratory studies- The QACi niaintaitts copies of study protaculs and standard operating 

procedures and has inspected this study on the da[c(s) listcd 1x;louc Studies lasting six months or 

more arc inspected at tinte intervals to assure the integrity of the study. The findings o£ thcsc 

imtpections have baen reported to managcmcnt and the Ctinical Director. All maicrials and data 

pertinent to this study 4vi71 be su7red in the Archives E`aciiity unless othcrwis: requexted by rhe 

sponsor. 

DatesoCiuspeetxutns: Auguat 16, 1993 

August 17, 1993 

Senior personnet involwedt 

7oy Frank, RN. - Executive Vicc President 

Clinic:;tt Hvaluations 

13everly Pin.sky - t,tinical I,aboxatory Supervisoc 

Clliver Shapirn, M.S, - Director of Quality Assnrattce and 

Regulatory Compliance 

The r_epresentative signaturct nC thn Quafity Assuiatice Unit on tkte. 1"ront pagn signifies that this 

siudy has been perfornted ui aecordanrc: aith standard operating procedures and study pron}eol s.s 

vvell Ggs govcrnmcnt reouiations tegardin sueii procedures "d protocols as outlined in the Federal 

Rcgistcr (VoL 46, No. 17 of "['uesday, lanuary 2;, L9811 

StAclnt[9n FZot7d - Pairfield. NewJcrscy0<004 a("-ant) 808-7t t I • I`aC 120l} 808-7234 
Page 3 

Objective: To determine by epidermal contact thc primary or cumulativc 

irritation ar,d/or sensitiza6on ps>tential of a test matefial. 

Participants: A panel contprised af fifty-seven (57) subjects, ranring in age froni 

17 to 75 years, wtto qualified were $elected ffiar this study. Fifty-two 

(52) subjeCts compieted this evalaation. The remaining subjects 

disc:ontinqed their participstion for variuus reasons, none of wlticll 

were related to the use of the test maEerial. 

Tha criteria for seieetion was: 

1. Willingness to cooperate, 

2. Absence of any vis?ble skin disease which mi ht be confosed 

with skin reactions from the test matcriat, 

3- Avoidance of usc of titpical or systeniic steroids andlor 

antihistamines for several days prior to study inifiation; 

4. Dependabitity and intelligence in following directions, and 

5. Reading, understanding and signinff an informed consent 

contrnct 

Test 7Vlaterlal: 

Study Schedule: Indtillton Date ComPietion Date 

fuly 7, 1993 August 13, 1993 

Methadolog}': As inskticted, prior h: the inft"rstiott of tftis study, the tCst materiat 

was dilutcd hy a Fuctor of five: from an activit yo uf approximately 

25% to 5'~~ . 

The upper back €x tween thc scapulae served as the treatment site.. 

Approximatcly 0,2 mT of the test material was applied to the 1" x 7" 

gauze portion of a Raadi-BandagcO adhesive dressing.* This was 

tlten appTied to the appropriate treatment site to form a 5emioccluded patch. 

This procedura was followed thrce fimes per week: Monday, 

Wedr,esday, and Friday far a total of ten applications. If a 

participant was unablc to rc:port for an a_ssigned test day, one (l) 

makeup day was permitted. This day was added to the Induction 

Period. Tttc sitc was tnarked to eneure the centXnuity of patch 

appllcatinn. The participants were instructed to remove this patch 

after twenty-foun cours. The avaluation of this site was rttade just 

prior to re-application. 

*Manufactttred by professional ;vledical Productc, Ync.., Grecnwnod, SC 
PaAe 4 

t4lethotlology 

(continued): Rest penods consisted of twenty-lirur tiours ir}llowing the Tuestlay 

and Thurs0ay renroval and forty-sight hours following the 5aturday 

rBmUVaI, 

At tlfe conclusion of a rest perioc# of approximatcly fourtecn days 

to[lowing the renth applicatic,n, a rhalicnge pareh wa- ~ applied tn the 

originat site and to a virgin site, Cach site tvas cvaluated at twenty 

four and forty-eiaht it0urs after application, The SFolar forearm 

scrvcd as thc vir ggan tcst sitc, 

Evatt ation Key; 0 

1+ 

2± 

3+ 

4+ 

No visihlc rcaction 

1!-iild crythcma 

WeIS-detined erythema, possibte presence ot 6arely 

perceptible ederna 

Erytlienia aiid edena 

Erythenra and edetnu ivith vesicuiation and uloeratiort 

ttesults; The resvtts ot' each participarrt are app2nded, t?hservations 

remained nil,pativc throuphitut thc tust interval, 

Sumnaary; [[nder the conditions of tltis study, test matorial, , 

does not indic<<tc a potcntiat far dermal irritatian or sensitiLation, 
Pa4e 5 

Tabte 1 

Indiyidual Rcsul[s 

p 

Snbject 

Numhcr 

--------°---inducFlon Exposut -es------ ------ 

1 2 i 4 5 6 7 8 9 10 

 C3ri~inal 

3ite 

24 48 

virgin 

Sitc 

24 48 

1 0 fi Ci 0 0 U 0 0 a 0 0 0 0 0 

2 0 0 0 () U t} 0 a 0 Om 0 0 0 0 

3 0 0 0 0 0 0 0'n 0 0 0 0 l) 0 0 

4 tl (I C 0 0 0 0 (l 0 Ci 0 Q U 0 

5 0 0 0 0 0 0 (l 0 0 0 0 p 0 4 

6 Sa (? Ci 0 tl Cl 0 Q 0 0 0 (I 0 0 

7 0 [l El tl lf 0 0 C) (tni 0 0 G ;] t1 

$ 0 0 0 U fJ {) i) (l 0 U l} U 0 U 

9 U 0 0 0 u 0 G 0 0 Om [) 0 0 U 

10 0 {) G iJ 0 0 0 0 0 f? 0 0 U 0 

11 i) 4n' U 0 tl (a 0 0 0 a 0 0 0 0 

12 a c) 0 0 0 0 0 0 CS 0 0 Q 0 U 

13 [) G 0 t} 0 0 U a C) 0 n 0 o U 

14 4 0 0 0 0 0 0 0 4 G [t U 0 0 

I 15 U 0 0 Uni 0 0 0 0 0 0 CI 41 [t 13 

16 {) 0 0 U [Y 0 0 0 G 0 D G 0 l7 

17 {l 0 0 0 1 {l {l 0 0 0111 {} 0 i7 tl 

1B 0 0 U G 0 U 0 U O 0 0 G 0 Q 

 lSt a G U Uni 0 {} {? 0 U cl {t q 

20 iT 0 0 U 0 U 0 U 0 C) U U 0 U 

21 C p U 0 0 0 Q () (} 0 b 0 0 0 

22 0 0 0 0 U 0 Uni 0 0 f} t) U 0 Q 

 23 0 0 0 0 0 0 0 (} 0 C7 (? 0 U 0 

24 0 U t} t) 0 f) G 0 p tt 0 0 0 G 

25 0 0M 0 (f t} 0 Cl O tt 0 tJ 0 0 4 

26 0 0 0 Cl 0 tl 0 0 Q 0 U [) p u 

 27 ti 0 U G, 0 0 0 0 tl 0n? 0 D 0 {1 

Z$ 0 ;} ii fJ 4 0 D On+ 0 U 0 0 f? Ci 

29 0 G 0 ll 0 U U tJ (1 {.? U 0 0 0 

30 Cl 0 0 pm U 0 0 0 U i) G p {Y 0 

ni = Iviakeup day 

~ 

I 
Paue 6 

Table 1 

(confinucd) 

Individual Resulis 

. 

~ 

Subject 

Nuaxbcr 

-------------Induclion ETpusures-------------- 

l 2 3 4 5 fr 7 $ 9 f(} 

O[iginal 

Sica 

24 48 

Virgin 

Sitc 

24 49 

31 0 t) t) 0 0 0 (l t} Cf 0 Q 0 LY t) 

32 ----------------------- ------- D1D NDT C(}NIPLETE STLR)Y ------------------ -°--- 

33 0 0 0 0 0 0 {) {} It 0 (s 0 0 Cr 

34 0 0 0 (i r_1 t) 0 I) 01 TI t} fi 0 0 0 

35 0 0 0 0 Q i} (l tiM 0 0 0 fi 0 i:I 

36 U ----------------------------DTTa N{)T t^t=1MPLHTE STUDY-------------------- 

37 0 0 U t} 0 0 U 0 c) 0 0 {I 0 0 

38 0 4 tl 0 0 0 4 {} [J CI 0 0 U ) 

39 U iI 0 0 0 U fl l} 0 0 Li tl 0 [> 

40 0 0 U 0 {) U Ct !} 0 0 [} t} 0 0 

41 0 (} 0 t7m {i 0 0 U 0 () t} 0 0 {} 

42 0 0 0 U 0 0 {} 0'n 0 (} 0 i i J 0 

43 {} 0 0111 ----------------DiD NCtT C(iMPLETE STUi)Y ------------------ — 

44 El U 0 0 11 [I 0 0 0 U t) 0 0 [{ 

45 0 0 0 t} U G! i} 0 (} 0 0 0 0 0 

46 0 {l U 0 0 {} 0 0 0 (l 0 [} t) (} 

47 G t) 0 (} (} 0 {"} {} 0 0 [t t) 0 0 

48 (} U 0 [} 0 U 0 U {) Q [l i} U 0 

=19 Om Ci 0 t) ---------------DID NOT C[)MPLETE S'I'UDY --------------- 

50 0 t} U G 0 0 {} 0 0 0 tJ 0 0 0 

51 t) tI 0 (l [7 0 0 t) [l 0 0 c) 0 U 

S2 o (t 0 a 0 0 0 Un, 0 n U 0 0 t? 

53 0 Ct cJ (}n' 0 0 ct (I 0 0 [? 0 U () 

54 (} t} 0 t} () 0"' Q C! 0 --DID NqT Ct3IvIPLF..TE STUIJY-- 

55 [i {Y t] (} 0 0 U 0 Q {} f) 0 ti t} 

56 0 0 (J 0 U 0 U 0 0 t3 ll C} U t} 

57 0 tt U 0 0 r}m (} p {} (} 0 

m - hiakcuP day 
Pauc 7 

Table 2 

Suhiec[ flaia 

Initials a1 ~ >e: SCa 

SC 59 

JFi 52 

LF ~ i 45 

MS 59 

PNI 4E 

KD 25 

NSL 3() 

DA 54 

YE? (7 

BM 44 

PO 37 

1L 46 

n11P 33 

AB 42 

FR 36 

SB 28 

I S 49 

KR 36 

4}I? 60 

SR 3G 

DV 50 

JV ^t3 

ChT 24 

{, }i 3? 

MC 35 

R7_ 54 

IS 58 

PL a'3 

CB 69 

I7B 33 
Page $ 

Table 2 

(cl5ntinUOd) 

Subjcct Data 

i itiaIS A ~ue 'Sex 

MC S3 

EC 58 

PS 24 

CR 4) 

IM 45 

L' W 18 

DC 43 

PM 29 

HP 55 

DG 44 

Dbi 32 

MiC 43 

B P 52 

LS 26 

R4W 75 

JR 69 

N4G 33 

WH 29 

AS 21 

AG 72 

SG 47 

FL 65 

NG 61 

KD 32 

MP 35 

DH 56 

V im 31