FDA.reportPublic FDA data

NERIUMRX COLD SORE THERAPY

Manufacturer
Nerium SkinCare, Inc.
Effective date
2019-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:09:47

Label at a glance#

ProductNERIUMRX COLD SORE THERAPY
Active ingredientCAMPHOR (NATURAL)
Label structure11 sections

Storage and handling

Transport and store in a cool dry place and keep away from direct sunlight.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 2%

OTC - PURPOSE SECTION

Fever Blister/Cold Sore Treatment

INDICATIONS & USAGE SECTION

● For the temporary relief of pain and itching associated with cold sores.

WARNINGS SECTION

For external use only.

OTHER SAFETY INFORMATION

Avoid contact with the eyes.

OTC - ASK DOCTOR SECTION

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE SECTION

● Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician

STORAGE AND HANDLING SECTION

Transport and store in a cool dry place and keep away from direct sunlight.

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Nerium oleander Leaf Extract (NAE-8®), Docosanol, Glycerin, Cocos Nucifera (Coconut) Oil, Arachidyl Alcohol, Cetearyl Olivate, Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Olea Europaea (Olive) Fruit Oil, Water (Aqua), Sorbitan Olivate, Sucrose Cocoate, Dimethicone, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Glyceryl Caprylate, Arachidyl Glucoside, Pelargonium Graveolens (Geranium) Flower Oil, Allantoin, Leuconostoc/Radish Root Ferment Filtrate, Xanthan Gum, Potassium Sorbate, Carrageenan, Benzyl Alcohol, Ascorbyl Palmitate, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Lysine HCL, Olea Europaea (Olive) Leaf Extract.

OTC - QUESTIONS SECTION

1-(866)-535-5888 M-F (9am to 5 pm CST)

DOSAGE & ADMINISTRATION SECTION

2% Topical Cream

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NERIUMRX®

COLD SORE

THERAPY

PROVIDES FAST-ACTING

PAIN RELIEF, STIMULATES

HEALING & REDUCES APPEARANCE

OF COLD SORE LESION

NEW TECHNOLOGY

PATENTED

NERIUM ALOE EXTRACT

Camphor 2.0% Cream

5 TREATMENT PODS

NERIUMRX® COLD SORE THERAPY, 2.5g/0.09 OZ.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NERIUMRX® COLD SORE THERAPYNERIUMRX® COLD SORE THERAPY

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72216-263-622023-04-06C16284748780-1ba0f9c33-51b3-a910-e053-dadaa90a0b85NERIUMRX COLD SORE THERAPY
72216-263-622021-01-29C16284748780-1ba0f9c33-51b3-a910-e053-dadaa90a0b85NERIUMRX COLD SORE THERAPY

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72216-26372216-263-61, 72216-263-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
BENZYL ALCOHOLLKG8494WBHIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
DIMETHICONE92RU3N3Y1OIACT
LINSEED OIL84XB4DV00WIACT
CETEARYL OLIVATE58B69Q84JOIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
GLYCERYL MONOUNDECYLENATEIK8A76Q5G8IACT
NERIUM OLEANDER LEAF7KV510R6H6IACT
DOCOSANOL9G1OE216XYIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
EGG SHELL MEMBRANEN7QBR4212VIACT
WATER059QF0KO0RIACT
SORBITAN OLIVATEMDL271E3GRIACT
SUCROSE COCOATE3H18P0UK73IACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
ALLANTOIN344S277G0ZIACT
OLIVE OIL6UYK2W1W1EIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CARRAGEENAN5C69YCD2YJIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
f8b1563e-877c-1dfc-e053-6294a90aec7992f04b30-c7c1-0f6f-e053-2a95a90a5ffd2023-04-06WarningsExact identifier
spl set id: 92f04b30-c7c1-0f6f-e053-2a95a90a5ffd

Reported adverse events (FAERS/openFDA)#

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