PURE NERIUM DERMAL PAIN RELIEF THERAPY- camphor 3% spray

PURE NERIUM DERMAL PAIN RELIEF THERAPY by

Drug Labeling and Warnings

PURE NERIUM DERMAL PAIN RELIEF THERAPY by is a Otc medication manufactured, distributed, or labeled by Nerium SkinCare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 3%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

● For the temporary relief of pain and itching.

WARNINGS

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.

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

INSTRUCTIONS FOR USE

● Shake before use. 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

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

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Nerium oleander Leaf Extract (NAE-8®), Glycerin, Water (Aqua), Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Pelargonium Graveolens (Geranium) Flower Oil, Allantoin, Capsicum Frutescens (Capsicum) Fruit Extract, Dimethicone, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Cetearyl Alcohol, Glyceryl Caprylate, Glyceryl Stearate, Leuconostoc/Radish Root 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

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

DOSAGE & ADMINISTRATION

3% TOPICAL LIQUID SPRAY

Principal Display Panel

PURE

NERIUM®

DERMAL PAIN

RELIEF THERAPY

With Camphor

Patented Nerium

Aloe Extract NAE-8®

Topical Analgesic

Liquid Spray

PURE NERIUM® DERMAL PAIN RELIEF THERAPY, 45ml/1.52 FL.OZ.

INGREDIENTS AND APPEARANCE

PURE NERIUM DERMAL PAIN RELIEF THERAPY 
camphor 3% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72216-337
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PULLULAN (UNII: 8ZQ0AYU1TT)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
ORANGE PEEL (UNII: TI9T76XD44)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
DIMETHICONE (UNII: 92RU3N3Y1O)
LINSEED OIL (UNII: 84XB4DV00W)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ALLANTOIN (UNII: 344S277G0Z)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
TABASCO PEPPER (UNII: J1M3NA843L)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72216-337-79	1 in 1 CARTON	09/30/2019
1	NDC: 72216-337-78	45 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2019

Labeler - Nerium SkinCare, Inc. (859420916)

Registrant - Nerium SkinCare, Inc. (859420916)