DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE- camphor, allantoin kit

DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE by

Drug Labeling and Warnings

DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE by is a Otc medication manufactured, distributed, or labeled by Nerium SkinCare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

COLD SORE THERAPY:

    CAMPHOR 2%

DAILY LIP MAINTENANCE:

    ALLANTOIN 0.5%

PURPOSE

COLD SORE THERAPY:

    FEVER BLISTER/COLD SORE TREATMENT

DAILY LIP MAINTENANCE:

    LIP PROTECTANT

USE

COLD SORE THERAPY:

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

DAILY LIP MAINTENANCE:

• Helps protect chapped lips

WARNINGS

COLD SORE THERAPY:

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.

DAILY LIP MAINTENANCE:

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

DIRECTIONS

COLD SORE THERAPY:

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.

DAILY LIP MAINTENANCE:

For adults use: apply daily as needed.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENTS

COLD SORE THERAPY:

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

DAILY LIP MAINTENANCE:

Aloe Barbadensis Leaf Juice, Glycerin, Propanediol, Nerium Oleander Leaf Extract (NAE-8®), Ethylhexyl Methoxycinnamate, Hydrolyzed Egg Shell Membrane (BiovaDerm®), Water (Aqua), Glyceryl Caprylate, Hydroxyethylcellulose, Glyceryl Stearate, Caprylic/Capric Triglyceride, Linum Usitatissimum (Linseed) Seed Oil, Carrageenan, Lysolecithin, Sclerotium Gum, Pelargonium Graveolens Flower
Oil, Leuconostoc/Radish Root Ferment Filtrate, Benzyl Alcohol, Pullulan, Xanthan Gum, Glyceryl Undecylenate, Potassium Sorbate, Butter Extract, Cocos Nucifera (Coconut) Fruit Extract, Cucumis Melo Cantalupensis Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Pimpinella Anisum (Anise) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Santalum Album (Sandalwood ) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Vanilla Planifolia Fruit Extract

QUESTIONS?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE 
camphor, allantoin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72216-212

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72216-212-22	1 in 1 BOX	05/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		1

Part 1 of 2

COLD SORE THERAPY 
camphor cream

Product Information
Item Code (Source)	NDC: 72216-102
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 mL

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/18/2018

Part 2 of 2

DAILY LIP MAINTENANCE 
allantoin cream

Product Information
Item Code (Source)	NDC: 72216-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)
OCTINOXATE (UNII: 4Y5P7MUD51)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LINSEED OIL (UNII: 84XB4DV00W)
CARRAGEENAN (UNII: 5C69YCD2YJ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PULLULAN (UNII: 8ZQ0AYU1TT)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTTER (UNII: 3B7C0987O9)
COCONUT OIL (UNII: Q9L0O73W7L)
CUCUMIS MELO VAR. CANTALUPENSIS WHOLE (UNII: HUU66O04OX)
BANANA (UNII: 4AJZ4765R9)
ANISE (UNII: 21C2F5E8RE)
APRICOT (UNII: 269CJD5GZ9)
APPLE (UNII: B423VGH5S9)
SANDALWOOD (UNII: 3641YW25N2)
CRANBERRY (UNII: 0MVO31Q3QS)
VANILLA (UNII: Q74T35078H)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part	05/18/2018

Labeler - Nerium SkinCare, Inc. (859420916)