FDA.reportPublic FDA data

Triderma Lipsore Cream

Manufacturer
Genuine Virgin Aloe Corporation
Effective date
2026-01-24
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:36:52

Label at a glance#

ProductTriderma Lipsore Cream
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Indications and uses

• speed healing of wounds, sores, acne and lip sores •helps promote healing of cuts, scrapes, chafing, minor burns and sunburn

Dosage and administration

•Read all package directions and warnings before use. When using this product use only as directed. Apply a thin layer to affected area and massage gently as soon as possible after minor injury. Apply 3X a day or as needed • Sensitivity Test for a N ew User . Apply sparingly to one or two small affected areas during the first 3 days. •i f no discomfort occurs , follow the direction stated above.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 1X HPUS 1.5%

HPUS indicates that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

Purpose

OTC - PURPOSE SECTION

Speed healing, Minimizes recurrence, healing agent.

Uses

INDICATIONS & USAGE SECTION

•speed healing of wounds, sores, acne and lip sores •helps promote healing of cuts, scrapes, chafing, minor burns and sunburn

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Intended for adults only.

OTC - DO NOT USE SECTION

Do not use if you are allergic to Calendula Officinalis or to this product's inactive ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use in case of deep puncture wounds, animal bites or serious burns and if condition worsens or does not improve within 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

•Read all package directions and warnings before use. When using this product use only as directed. Apply a thin layer to affected area and massage gently as soon as possible after minor injury. Apply 3X a day or as needed • Sensitivity Test for a N ew User. Apply sparingly to one or two small affected areas during the first 3 days. •i f no discomfort occurs, follow the direction stated above.

Other information

OTHER SAFETY INFORMATION

Do not use if glued carton end flaps are open or if the tube seal is broken. •store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetearyl alcohol, isopropyl palmitate, polysorbate 60, cera alba(beeswax), dimethicone, allantoin, zinc PCA, avena sativa (oat) kernel flour, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), cetyl alcohol, sodium PCA, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.

Questions?

OTC - QUESTIONS SECTION

1-800-279-7282 M-F 8am-4pm PST

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triderma MD

Lipsore Healing Cream

Speeds healing of wounds & lip sores

Soothes and Moisturizes




Calendula
Homeopathic Medicine

NET WT. 0.5 oz (14 g)

Tube LabelTube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10738-020-552023-02-08C16284748780-1f386c64a-086c-0266-e053-dadaa90a7c1aTriderma Lipsore Healing Cream
10738-020-552023-01-30C16284748780-1f386c64a-086c-0266-e053-dadaa90a7c1aTriderma Lipsore Healing Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10738-020-55Triderma Lipsore Cream14 g in 1 TUBECREAM149

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10738-02010738-020-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHYTATE SODIUM88496G1ERLIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
POLYSORBATE 60CAL22UVI4MIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
ALLANTOIN344S277G0ZIACT
ZINC PIDOLATEC32PQ86DH4IACT
OATMEAL8PI54V663YIACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT

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
Triderma Lipsore CreamCALENDULA OFFICINALISGenuine Virgin Aloe Corporationc11f879a-5dc0-724d-e053-2995a90a8aa62026-01-24WarningsExact identifier
ndc (package): 10738-020-55
ndc (product): 10738-020
ndc11 (package): 10738002055
spl id: 492965c9-0cf4-8bae-e063-6394a90ae6b3
spl set id: c11f879a-5dc0-724d-e053-2995a90a8aa6

Reported adverse events (FAERS/openFDA)#

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