hemorrhoidal
hemorrhoidal, A+ Health
Approved
Approval ID
1790da99-2a22-e2a2-e063-6394a90ac36f
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mineral oil, petrolatum, phenylephrine hcl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-448
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
mineral oil, petrolatum, phenylephrine hcl
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (16)
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
PETROLATUMActive
Quantity: 749 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 g
Code: 04JA59TNSJ
Classification: ACTIM
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MINERAL OILActive
Quantity: 140 mg in 1 g
Code: T5L8T28FGP
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
THYME OILInactive
Code: 2UK410MY6B
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT