FDA.reportPublic FDA data

DERMAL PAIN RELIEF THERAPY

Manufacturer
Nerium SkinCare, Inc.
Effective date
2018-05-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:57:56

Label at a glance#

ProductDERMAL PAIN RELIEF THERAPY
Active ingredientCAMPHOR (NATURAL)
Label structure9 sections

Indications and uses

For the temporary relief of pain and itching

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CAMPHOR 3%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain and itching

WARNINGS

WARNINGS SECTION

For external use only
Avoid contact with the eyes.
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

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

DIRECTIONS

DOSAGE & ADMINISTRATION 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.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Nerium oleander Leaf Extract, Glycerin, Water (Aqua), Hydrolyzed Egg Shell Membrane, Pelargonium Graveolens Flower Oil, Allantoin, Capsicum Frutescens Fruit Extract, Dimethicone, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Cetearyl Alcohol, Glyceryl Caprylate, Glyceryl Stearate, Leuconostoc/Radish Room Ferment Filtrate, Citrus Aurantium Dulcis (Orange) Peel Extract, Sodium Lauroyl Glutamate, Stearic Acid, Lysolecithin, Sclerotium Gum, Potassium Sorbate, Microcrystalline Cellulose, Benzyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Lysine HCL, Menthol, Pullulan, Xanthan Gum, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cellulose Gum, Olea Europaea (Olive) Leaf Extract

QUESTIONS?

OTC - QUESTIONS SECTION

1-(844)-599-7787 M-F (9 am to 5 pm CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nerium Dermal Pain Relief Therapy_UC_30mLNerium Dermal Pain Relief Therapy_UC_30mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72216-104-112023-04-06C16284748780-1ba0f9c33-192e-a910-e053-dadaa90a0b85DERMAL PAIN RELIEF THERAPY
72216-104-112021-01-29C16284748780-1ba0f9c33-192e-a910-e053-dadaa90a0b85DERMAL PAIN RELIEF THERAPY

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72216-10472216-104-01, 72216-104-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
NERIUM OLEANDER LEAF7KV510R6H6IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
EGG SHELL MEMBRANEN7QBR4212VIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
ALLANTOIN344S277G0ZIACT
CAPSICUM FRUTESCENS WHOLE6XJX33L87PIACT
DIMETHICONE92RU3N3Y1OIACT
LINSEED OIL84XB4DV00WIACT
TOCOPHEROLR0ZB2556P8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
ORANGE PEELTI9T76XD44IACT
SODIUM LAUROYL GLUTAMATENCX1UU2D33IACT
STEARIC ACID4ELV7Z65APIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BETASIZOFIRAN2X51AD1X3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BENZYL ALCOHOLLKG8494WBHIACT
LAVENDER OILZBP1YXW0H8IACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
MENTHOLL7T10EIP3AIACT
PULLULAN8ZQ0AYU1TTIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
TEA TREE OILVIF565UC2GIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT

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
f8b0f068-83c5-a208-e053-6294a90aab9182dbfc33-0b32-4a7e-a340-224ff2d9a2502023-04-06WarningsExact identifier
spl set id: 82dbfc33-0b32-4a7e-a340-224ff2d9a250

Reported adverse events (FAERS/openFDA)#

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