FDA.reportPublic FDA data

Mederma ® CREAM

Manufacturer
Merz Pharmaceuticals, LLC
Effective date
2022-02-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:07:56

Label at a glance#

ProductMederma
Active ingredientAVOBENZONE, OCTOCRYLENE, OXYBENZONE
Label structure8 sections

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Mederma® Cream should be evenly applied and gently rubbed into the scar 3 times daily for 8 weeks on new scars, and 3 times daily for 3–6 months on existing scars. Also apply Mederma® Cream to the scar before sun exposure.

OTC - ASK DOCTOR SECTION

Children under 6 months of age: ask a doctor.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%, OCTOCRYLENE 10%, OXYBENZONE 6%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, ALLIUM CEPA (ONION) BULB EXTRACT, C12-15 ALKYL BENZOATE, DICAPRYLYL CARBONATE, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, PANTHENOL, PENTYLENE GLYCOL, PHENOXYETHANOL, BUTYROSPERMUM PARKII (SHEA BUTTER), GLYCERIN, AMMONIUM ACRYLOYL-DIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE, SQUALANE, METHYLPARABEN, XANTHAN GUM, DISODIUM EDTA, CERAMIDE 3, SODIUM HYALURONATE, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - DO NOT USE SECTION

Do not use on open wounds.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STORAGE AND HANDLING SECTION

Store at room temperature.

OTC - QUESTIONS SECTION

For more information call 1-888-925-8989 or visit www.mederma.com

SPL UNCLASSIFIED SECTION

Manufactured for Merz Pharmaceuticals, Greensboro, NC 27410
Made in Germany © 2007 Merz Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 20 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKIN CARE FOR SCARS™
MEDERMA®
+SPF 30
SCAR
CREAM

NET WT. 0.70 OZ. (20g)
MERZ

PRINCIPAL DISPLAY PANEL - 20 g Tube Carton
PRINCIPAL DISPLAY PANEL - 20 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0259-3192-052022-02-24C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-202022-02-24C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-502022-02-24C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-052022-01-28C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-202022-01-28C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-502022-01-28C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-052020-02-07C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-202020-02-07C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-502020-02-07C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-052020-01-31C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-202020-01-31C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM
0259-3192-502020-01-31C16284748780-19d75b9d0-8f2f-f424-e053-dadaa90a57ceMederma ® CREAM

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0259-3192-20GM - Gram0259-3192aa039d6e-7daf-4ede-b055-1a371b848c1a12022-06-06
0259-3192-50GM - Gram0259-31922c797962-2b30-4377-b40e-505e89bd953512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0259-31920259-3192-05, 0259-3192-20, 0259-3192-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
ONION492225Q21HIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PANTHENOLWV9CM0O67ZIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SQUALANEGW89575KF9IACT
METHYLPARABENA2I8C7HI9TIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
CERAMIDE NP4370DF050BIACT
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYLPARABEN3QPI1U3FV8IACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
C12-15 ALCOHOLS2C8M6XLB5CIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1380b880-f423-4f19-b8d3-e72002a797e96aee317e-514e-4336-beb1-384bb5cde9f52022-02-22WarningsExact identifier
spl id: 1380b880-f423-4f19-b8d3-e72002a797e9
spl set id: 6aee317e-514e-4336-beb1-384bb5cde9f5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.