FDA.reportPublic FDA data

Dynamiclear ORO

Manufacturer
Dynamiclear Partners LLC | ACTIV PHARMACEUTICALS PTY LTD
Effective date
2016-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:16

Label at a glance#

ProductDynamiclear ORO
Active ingredientCAMPHOR (NATURAL)
Label structure10 sections

Indications and uses

Pain Relief Relieves Burning and Itching Fever Blister/Cold Sore Relief

Dosage and administration

 Adults and Children 12 years and older  Single Application  Children under 12  Use under adult supervision only  Children under 2 years  Do not use consult a physician Apply a single application to each outbreak as needed. Repeat application may not be necessary.  If symptoms persist over 24hr apply another single application.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Purpose

OTC - PURPOSE SECTION

Fever Blister/

Cold Sore Treatment

External Analgesic

Uses

INDICATIONS & USAGE SECTION

Pain Relief

Relieves Burning and Itching

Fever Blister/Cold Sore Relief

Warnings

WARNINGS SECTION

For External Use Only

In case of overdose, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

Ask a doctor or pharmacist before use if you have any questions about this product

When using this product

WARNINGS SECTION

Do not get into eyes

Stop use and ask a doctor if

WARNINGS SECTION

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

WARNINGS SECTION

If pregnant or breastfeeding ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and Children

12 years and older

 Single Application

 Children under 12

 Use under adult

supervision only

 Children under 2

years

 Do not use consult

a physician

Apply a single application to each outbreak as needed.

Repeat application may not be necessary.  If symptoms

persist over 24hr apply another single application.

Other Information:

OTHER SAFETY INFORMATION

A slight sting may be felt when applying at blistered stage.

When applying to active blisters the scab occasionally turns dark before falling off within a few days.

Store at 15-30C (59-86F) Away from Heat & Direct Sunlight.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

glycerol, isopropyl alcohol, polyethylene glycol, cupric sulfate, polysorbate, vitamin e, calendula officinalis, hypericum perforatum, aloe vera

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70955-886-012022-01-30C16284748780-19d75b9d0-1663-f424-e053-dadaa90a57ceDynamiclear ORO
70955-886-012020-01-31C16284748780-19d75b9d0-1663-f424-e053-dadaa90a57ceDynamiclear ORO

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70955-88670955-886-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
GLYCERINPDC6A3C0OXIACT
CUPRIC SULFATELRX7AJ16DTIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYSORBATE 806OZP39ZG8HIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT

Source Document#

Source XML · Source PDF

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
d6a9711e-b627-f1bc-e053-2995a90a8c0f46688e9b-5473-4bda-bcf8-dad206a39d0d2022-01-28WarningsExact identifier
spl set id: 46688e9b-5473-4bda-bcf8-dad206a39d0d

Reported adverse events (FAERS/openFDA)#

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