NDC | 72216-212-22 |
Set ID | 2fd37f9f-c4df-4cb5-9c31-3b22974f5748 |
Category | HUMAN OTC DRUG LABEL |
Packager | Nerium SkinCare, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART |
- ACTIVE INGREDIENT
- PURPOSE
- USE
-
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
- 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?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE
camphor, allantoin kitProduct 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 creamProduct 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 creamProduct 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)