FDA.reportPublic FDA data

Bruise MD

Manufacturer
Newmedical Technology, Inc.
Effective date
2023-06-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:55:12

Label at a glance#

ProductNewGel Plus SPF
Active ingredientZINC OXIDE, ALLANTOIN
Label structure6 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose Zinc Oxide 20% SunscreenPurpose Zinc Oxide 20% Sunscreen

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

WARNINGS SECTION

WarningsWarnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC-Keep out of Reach of ChildrenOTC-Keep out of Reach of Children

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% SunscreenZinc Oxide 20% Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Silagen Bottle Pump 69291-6215-2Silagen Bottle Pump 69291-6215-2Silagen CartonSilagen CartonSilagen BottleSilagen BottleSilagen CartonSilagen CartonPackage LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442087allantoin 0.5 % Topical GelPSN8
1442087allantoin 0.005 MG/MG Topical GelSCD8
1442087allantoin 0.5 % Topical GelSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69291-8050-22024-07-30C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-9020-12024-07-30C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-8050-22024-01-30C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-9020-12024-01-30C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-8050-22022-03-15C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-9020-12022-03-15C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-8050-22022-01-28C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-9020-12022-01-28C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-8050-22021-09-10C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-9020-12021-09-10C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-8050-22021-07-23C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c
69291-9020-12021-07-23C16284748780-1c7ccaba7-12c9-fd44-e053-dadaa90aa01b486c4a51-9edc-3999-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69291-8050-2NewGel Plus SPF15 g in 1 BOTTLEGEL158
69291-9020-1Bruise MD1 in 1 CARTONGEL18
69291-9020-2Bruise MD20 g in 1 TUBEGEL208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69291-8050NEWGEL PLUS SPF (ZINC OXIDE, SUNSCREEN) GEL BRUISE MD (ALLANTOIN) GEL [NEWMEDICAL TECHNOLOGY, INC.]8Legacy NDC, 1 package rows20230609_486c4a51-9edc-3999-e054-00144ff8d46c.zip
69291-9020NEWGEL PLUS SPF (ZINC OXIDE, SUNSCREEN) GEL BRUISE MD (ALLANTOIN) GEL [NEWMEDICAL TECHNOLOGY, INC.]8Legacy NDC, 2 package rows20230609_486c4a51-9edc-3999-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69291-805069291-8050-2
69291-902069291-9020-2, 69291-9020-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BROMELAINSU182GP2CF3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLUCOSYL HESPERIDIN432C95B6YEIACT
CARBOMER 9404Q93RCW27EIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
ALLANTOIN344S277G0ZACTIB
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWIACT
SODIUM LACTATETU7HW0W0QTIACT
.ALPHA.N-(METHOXYCARBONYL)-L-ARGININEPE4EFA9P6EIACT
PHYTONADIONEA034SE7857IACT
NIACINAMIDE25X51I8RD4IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT

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
fda3bb96-7606-a5b6-e053-6294a90a792e486c4a51-9edc-3999-e054-00144ff8d46c2023-06-08WarningsExact identifier
spl id: fda3bb96-7606-a5b6-e053-6294a90a792e
spl set id: 486c4a51-9edc-3999-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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