COLD SORE SUPPORT

Manufacturer
MiraCell Inc | Health Specialty.com
Effective date
2013-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:38:43

Label at a glance#

ProductCOLD SORE SUPPORT
Active ingredientALLANTOIN, AVOBENZONE, MENTHOL, OCTINOXATE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Allantoin 0.75%
Avobenzone 2.5%
Menthol 1.0%
Octinoxate 5.5%
Zinc Oxide 3.5%

OTC - PURPOSE SECTION

Purpose


Skin Protectant
Sunscreen
External Analgesic
Sunscreen
Sunscreen

INDICATIONS & USAGE SECTION

Uses:

  • for the temporary relief of the pain and itching associatedwith fever blisters and cold sores
  • provides moderate protectionagainst sunburn
  • temporarily protects chapped or cracked lips

WARNINGS SECTION

Warnings: external use only

DOSAGE & ADMINISTRATION SECTION

Directions:

  • for cold sores/chapped lips, apply to lips with the first symptoms and as often as needed
  • for sunscreen, reapply every 2 hrs

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Camellia Kissi Oil, Helianthus Annuus (Sunflower) Seed Oil, L-Lysine, Euphorbia Cerifera (Candelilla) Wax, Melissa Officinalis Leaf Oil (Lemon Balm), Tocopherol, Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Echinacea Angustifolia Leaf Extract, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Extract, Natural Lemon Flavor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LipSupport_Box_Short_v15LipSupport_Box_Short_v15

LipSupport_label_v15LipSupport_label_v15

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130660403250633GTIN-13: 0660403250633
EAN-13: 0660403250633
GTIN-12: 660403250633
UPC-A: 660403250633
GTIN storage (14 digits): 00660403250633
LipSupport_label_v15.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61223-101-212024-04-01C16284748780-19855e2a2-4ea2-60a7-e053-dbdaa90a05bdb1200a6a-254b-4032-89cd-025f91fcc754
61223-101-212019-11-27C16284748780-19855e2a2-4ea2-60a7-e053-dbdaa90a05bdb1200a6a-254b-4032-89cd-025f91fcc754

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z1
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ALLANTOINACTIVE MOIETY344S277G0Z1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
MENTHOLACTIVE MOIETYL7T10EIP3A1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ZINC CATIONACTIVE MOIETY13S1S8SF371
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYX1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CAMELLIA KISSII SEED OILINACTIVE INGREDIENT96HGN0T99A1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
ECHINACEA ANGUSTIFOLIA LEAFINACTIVE INGREDIENTFS7G8S6PJ81
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LEMON BALM OILINACTIVE INGREDIENTMJ76269K9S1
LEMON OILINACTIVE INGREDIENTI9GRO824LL1
LYSINEINACTIVE INGREDIENTK3Z4F929H61
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
STEVIA REBAUDIANA WHOLEINACTIVE INGREDIENT6U422Y08O21
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61223-10161223-101-11, 61223-101-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 47 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
LYSINELYSINEK3Z4F929H6INJECTION, SOLUTION / INTRAVENOUS0.22 %w/vExact identifier — unii candidate
3 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
LYSINELYSINEK3Z4F929H6INJECTION / INTRAVENOUS0.61 %w/vExact identifier — unii candidate
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
LYSINELYSINEK3Z4F929H6INJECTION / INTRAMUSCULARNAExact identifier — unii candidate
3 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLSUSPENSION / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
150ed7c8-13d3-9db9-e063-6394a90aa082b1200a6a-254b-4032-89cd-025f91fcc7542024-04-01WarningsExact identifier
spl set id: b1200a6a-254b-4032-89cd-025f91fcc754

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.