Cold Sore Rescue: Homeopathic Product Information

COLD SORE RESCUE- sodium borate, solanum dulcamara top, sodium chloride, ranunculus bulbosus whole and silicon dioxide gel
Peaceful Mountain, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:


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

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.

WARNINGS:

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:

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

DIRECTIONS:

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

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.

INACTIVE INGREDIENTS:

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:

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:

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 Tube
(click image for full-size original)
Cold Sore Rescue Carton
(click image for full-size original)
COLD SORE RESCUE
borax, dulcamara, natrum muriaticum, ranunculus bulbosus, silicea gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BORATE (BORATE ION) SODIUM BORATE 30 [hp_X] in 1 g
SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP) SOLANUM DULCAMARA TOP 30 [hp_X] in 1 g
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X] in 1 g
RANUNCULUS BULBOSUS WHOLE (RANUNCULUS BULBOSUS WHOLE) RANUNCULUS BULBOSUS WHOLE 30 [hp_X] in 1 g
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 30 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
ARNICA MONTANA FLOWER
CARBOMER HOMOPOLYMER TYPE C
LARREA TRIDENTATA LEAF
COMFREY LEAF
EDETATE DISODIUM
LAVANDULA ANGUSTIFOLIA FLOWER
MELISSA OFFICINALIS LEAF
OREGANO
POLYETHYLENE GLYCOL 1600
PEG-8 DIMETHICONE
POLYETHYLENE GLYCOL 700
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
PHYTOLACCA AMERICANA FRUIT
PHYTOLACCA AMERICANA ROOT
POTASSIUM SORBATE
WATER
SODIUM HYDROXIDE
ST. JOHN’S WORT
ASCORBIC ACID
.ALPHA.-TOCOPHEROL
SALIX ALBA BARK
ACHILLEA MILLEFOLIUM FLOWER
CITRIC ACID MONOHYDRATE
ALCOHOL
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43846-0031-2 1 TUBE in 1 CARTON contains a TUBE (43846-0031-1)
1 NDC:43846-0031-1 7 g in 1 TUBE This package is contained within the CARTON (43846-0031-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/08/2014
Labeler — Peaceful Mountain, Inc. (078430707)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (43846-0031), api manufacture (43846-0031), label (43846-0031), pack (43846-0031)

Revised: 08/2022 Peaceful Mountain, Inc.

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