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Allergens

Thanks to Trisha Potter for this documentation:

ALLERGEN PATCH TEST KIT: The Allergen Patch Test kit includes a group of substances which are associated with contact dermatitis. The kit contains 20 allergen-filled, multiple-dose syringes intended for topical use only and not for parenteral injection. Patch testing to multiple allergens has frequently been utilized as a diagnostic "screen." Where patient history has implicated a single allergen, patients have sometimes been tested to that allergen only.

The Allergen Patch Tests are prepared from the purest grade of source materials generally available and are suspended in 4.5 grams of petrolatum or dissolved in 5.5 grams of water. Each lot is assayed and determined to contain +/- 20% of the labeled value of the test substance or mixture. The components of some Allergen Patch Test mixtures, e.g., thiuram mix, have been shown to chemically interact, resulting in the formation of new substances.

Allergen Patch Tests are subjected to microbial analysis to assure a microbial load of no more than 102 organisms/ml and absence of Salmonella, Shigella, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa. The Allergen Patch Test is not certified as sterile. The estimated application dosage for each Allergen Patch Test is based on a 5-mm ribbon of petrolatum base or 1 drop of water. The Allergen Patch Test kit contains the following individually labeled allergen-filled reclosable syringes:

1. benzocaine, 5% in petrolatum, USP (0.68 mg/application)
2. mercaptobenzothiazole, 1% in petrolatum, USP (0.14 mg/application)
3. colophony, 20% in petrolatum, USP (2.7 mg/application, of which not less than 70% {1.9 mg} is abietic acid
4. p-phenylenediamine, 1% in petrolatum, USP(0.14 mg/application)
5. imidazolidinyl urea (Germall 115), 2% in water for injection (0.95 mg/application)
6. cinnamic aldehyde, 1% in petrolatum, USP (0.14 mg/application)
7. lanolin alcohol (wool wax alcohols), 30% in petrolatum, USP(4.1 7. 7. mg/application, of which not less than 30% {1.2 mg} is cholesterol)
8. carba mix (carba rubber mix), 3% in petrolatum, USP (0.41 mg/application), with 1,3-diphenylguanidine 1% (0.14 mg/application), zinc diethyldithiocarbamate 1% (0.14 mg/application) and zinc diethyldithiocarbamate 1% (0.14 mg/application).
9.neomyicn sulfate, 20% in petrolatum, USP (2.7 mg/application)
thiuram mix (thiuram rubber mix), 1% in petrolatum, USP (0.14 mg/application) with tetramethylthiuram disulfide 0.25% (0.034 mg/application), tetramethylthiuram monosulfide 0.25% (0.034 mg/application), tetraethylthiuram disulfide 0.25% (0.034 mg/application) and dipentamethylenethiuram disulfide 0.25% (0.034 mg/application)
10. formaldehyde (contains methanol), 1% in water for injection (0.47 mg/application)
11. ethylenediamine dihydrochloride, 1% in petrolatum, USP (0.14 mg/application)
12. epoxy resin, 1% in petrolatum, USP (0.14 mg/application)
quaternium-15 (N-{3-chloroallyl}-hexaminium chloride), 2% in petrolatum, USP (0.27 mg/application)
13. p-tert.-butylphenol formaldehyde resin, 1% in petrolatum, USP (0.14 mg/application)
14. mercapto mix (mercapto rubber mix), 1% in petrolatum, USP (0.14 mg/application) with N-cyclohexyl-2-benzothiazole-sulfenamide 0.333% (0.045 mg/application), 2,2'-benzothiazyl disulfide 0.333% (0.045 mg/application) and morpholinylmercaptobenzothiazole 0.333% (0.045 mg/application)
15. black rubber p-phenylenediamine mix (P.P.D.), 0.6% in petrolatum, USP (0.81 mg/application) with N-phenyl-N'-cyclohexyl-p-phenylenediamine 0.25% (0.034 mg/application), N-isopropyl-N'-phenyl-p-phenylenediamine 0.10% (0.14 mg/application) and N,N'-diphenyl-p-phenylenediamine 0.25% (0.034 mg/application)
16. potassium dichromate, 0.25% in petrolatum, USP (equivalent to 0.088% chromium, 0.012 mg chromium/application)
17. balsam of peru, 25% in petrolatum, USP (3.4 mg/application, of which not less than 35% {1.2 mg/application} is benzylbenzoate and not less than 10% {0.34 mg/application} is benzylcinnamate)
18. nickel sulfate (anhydrous), 2.5% in petrolatum, USP (equivalent to 0.95% nickel, 0.13 mg nickel/application)


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