Cotton
Allergenic Extract
Approved
Approval ID
5e05dd21-ad47-420d-abf2-72fff134f977
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Orris Root
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2235
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Orris Root
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
IRIS GERMANICA VAR. FLORENTINA ROOTActive
Quantity: 0.05 g in 1 mL
Code: M30XO5X4XD
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Flaxseed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2219
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Flaxseed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
FLAX SEEDActive
Quantity: 0.05 g in 1 mL
Code: 4110YT348C
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Jute
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2251
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Jute
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
CORCORUS CAPSULARIS FIBERActive
Quantity: 0.05 g in 1 mL
Code: TVA75O7S63
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Sisal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2259
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sisal
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
AGAVE SISALANA FIBERActive
Quantity: 0.05 g in 1 mL
Code: MRJ91HVV4H
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Kapok
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2227
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Kapok
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
CEIBA PENTANDRA FIBERActive
Quantity: 0.05 g in 1 mL
Code: 758Z9H9WV9
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Cotton
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2195
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cotton
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
COTTONActive
Quantity: 0.05 g in 1 mL
Code: 7S4U9R5259
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Cotton Seed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2211
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cotton Seed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
COTTON SEEDActive
Quantity: 0.05 g in 1 mL
Code: DI0ZRJ0MXN
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Cotton Linters
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2203
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cotton Linters
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (6)
COTTON FIBERActive
Quantity: 0.05 g in 1 mL
Code: 70LDW53ROO
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT