adapalene and benzoyl peroxide swab
These highlights do not include all the information needed to use Adapalene and Benzoyl Peroxide Gel safely and effectively. See full prescribing information for Adapalene and Benzoyl Peroxide Swabs.Adapalene and Benzoyl Peroxide Gel 0.1% / 2.5% For topical useInitial U.S. Approval:
Approved
Approval ID
5510c3a7-08c4-42bd-b610-6b9fc143c1ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2020
Manufacturers
FDA
Biomes Pharmaceuticals
DUNS: 078644310
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adapalene and benzoyl peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69150-001
Product Classification
G
Generic Name
adapalene and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 22, 2020
FDA Product Classification
INGREDIENTS (11)
BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
POLOXAMER 182Inactive
Code: JX0HIX6OAG
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT