PURE NERIUM COLD SORE THERAPY- camphor 2% cream

PURE NERIUM COLD SORE THERAPY by

Drug Labeling and Warnings

PURE NERIUM COLD SORE 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 2%

PURPOSE

Fever Blister/Cold Sore Treatment

INDICATIONS & USAGE

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

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

● 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®), 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.

QUESTIONS

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

DOSAGE & ADMINISTRATION

2% Topical Cream

Principal Display Panel

PURE

NERIUM®

COLD SORE

THERAPY CREAM

With Camphor

Patented Nerium

Aloe Extract NAE-8®

PURE NERIUM® COLD SORE THERAPY CREAM, 3.5g/0.12 OZ.

INGREDIENTS AND APPEARANCE

PURE NERIUM COLD SORE THERAPY 
camphor 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72216-265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIMETHICONE (UNII: 92RU3N3Y1O)
LINSEED OIL (UNII: 84XB4DV00W)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SUCROSE COCOATE (UNII: 3H18P0UK73)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ALLANTOIN (UNII: 344S277G0Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CARRAGEENAN (UNII: 5C69YCD2YJ)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72216-265-72	1 in 1 CARTON	09/18/2019
1	NDC: 72216-265-71	3.5 g in 1 BOTTLE, PUMP; 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	09/16/2019

Labeler - Nerium SkinCare, Inc. (859420916)

Registrant - Nerium SkinCare, Inc. (859420916)