FDA.reportPublic FDA data

Cold Sore Rescue

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2024-06-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:27:21

Label at a glance#

ProductCold Sore Rescue
Active ingredientSODIUM BORATE, SOLANUM DULCAMARA TOP, SODIUM CHLORIDE, RANUNCULUS BULBOSUS WHOLE, SILICON DIOXIDE
Label structure9 sections

Indications and uses

May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Apply at least 3 times daily over affected area. Children under 12 years of age: Consult a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION


(in gel): 0.20% of BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X.

USES:

OTC - PURPOSE SECTION

May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For external use only.

When using this product - Do not get into eyes.

Stop use and ask a doctor if: Condition worsens - Symptoms last more than 7 days

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply at least 3 times daily over affected area. Children under 12 years of age: Consult a doctor.

USES:

INDICATIONS & USAGE SECTION

May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Chaparral (Larrea Tridentata) Leaf, Comfrey (Symphytum Officinale) Leaf, St. John’s Wort (Hypericum Perforatum) Aerial Parts, Poke (Phytolacca Americana) Root, Arnica (Arnica Montana) Flower, Lemon Balm (Melissa Officinalis) Leaf, White Willow (Salix Alba) Bark, Yarrow (Achillea Millefolium) Flower, English Lavender (Lavandula Angustifolia) Buds, Ascorbic Acid, Poke (Phytolacca Americana) Berries, Aloe Vera 10X Concentrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Alcohol, Citric Acid.

QUESTIONS:

OTC - QUESTIONS SECTION

888-303-3388 Mon-Fri 8 a.m.-5 p.m. CT

Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

homeopathic relief

May temporarily relieve cold sore and fever blisters symptoms

May help temporarily relieve stinging, burning, itching and swelling

peaceful mountain

THE HEIGHT OF HEALTH

formulated in boulder, co

cold sore rescue

homeopathic gel

Net wt. 0.25 oz. (7 g)

Cold Sore Rescue TubeCold Sore Rescue Tube

Cold Sore Rescue CartonCold Sore Rescue Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0031-22024-06-13C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0031-22024-01-30C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0031-22020-04-24C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0031-22020-01-31C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43846-0031-1Cold Sore Rescue7 g in 1 TUBEGEL76
43846-0031-2Cold Sore Rescue1 in 1 CARTONGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0031COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]6Current NDC, Legacy NDC, 2 package rows20240615_a7fe6ec7-a758-43cf-b46f-c327e0632fb8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
RANUNCULUS BULBOSUSACTIVE INGREDIENTAEQ8NXJ0MB1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QO1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162N1
BORATE IONACTIVE MOIETY44OAE30D221
CHLORIDE IONACTIVE MOIETYQ32ZN486981
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
RANUNCULUS BULBOSUSACTIVE MOIETYAEQ8NXJ0MB1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162N1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ACHILLEA MILLEFOLIUM FLOWERINACTIVE INGREDIENTYQR8R0SQEA1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
LARREA TRIDENTATA TOPINACTIVE INGREDIENTPK0TXD049P1
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE92191
OREGANOINACTIVE INGREDIENT0E5AT8T16U1
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764OD1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHYTOLACCA AMERICANA FRUITINACTIVE INGREDIENTWE636614991
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEG1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5R1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H71
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKA1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-003143846-0031-1, 43846-0031-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BORATE91MBZ8H3QOACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
RANUNCULUS BULBOSUS WHOLEAEQ8NXJ0MBACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
LARREA TRIDENTATA LEAFPK0TXD049PIACT
COMFREY LEAFDG4F8T839XIACT
EDETATE DISODIUM7FLD91C86KIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
OREGANO0E5AT8T16UIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
PHYTOLACCA AMERICANA FRUITWE63661499IACT
PHYTOLACCA AMERICANA ROOT11E6VI8VEGIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
ST. JOHN'S WORTUFH8805FKAIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SALIX ALBA BARK205MXS71H7IACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT
SODIUM BENZOATEOJ245FE5EUIACT

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 · 39 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii+route
9 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route
9 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii+route
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ASOLUTION / TOPICAL29.7 %w/wExact identifier — unii+route
6 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii+route
6 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33AGEL / DENTAL5 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii+route
9 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33AGEL / DENTAL5 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii+route
9 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ASOLUTION / TOPICAL29.7 %w/wExact identifier — unii+route
6 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii+route
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii+route
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33AGEL / DENTAL5 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route
9 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ASOLUTION / TOPICAL29.7 %w/wExact identifier — unii+route
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii+route
6 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
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
ndc (package): 43846-0031-1
ndc (package): 43846-0031-2
ndc (product): 43846-0031
ndc11 (package): 43846003102
ndc11 (package): 43846003101
spl id: c8fdf831-1f89-45a8-b490-b21d87580449
spl set id: a7fe6ec7-a758-43cf-b46f-c327e0632fb8

Reported adverse events (FAERS/openFDA)#

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