DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE- camphor, allantoin 
Nerium SkinCare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nerium (as PLD) - DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE (72216-212) - DELIST

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.

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)

Dual Treatment Kit_UC

DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE 
camphor, allantoin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72216-212
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72216-212-221 in 1 BOX05/18/201812/31/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 1 of 2
COLD SORE THERAPY 
camphor cream
Product Information
Item Code (Source)NDC:72216-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/18/201812/31/2019
Part 2 of 2
DAILY LIP MAINTENANCE 
allantoin cream
Product Information
Item Code (Source)NDC:72216-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01603/21/201312/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart05/18/201812/31/2019
Labeler - Nerium SkinCare, Inc. (859420916)

Revised: 4/2023
 
Nerium SkinCare, Inc.