Active Ingredients:
BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X
Cold Sore Rescue Gel
FDA Label NDC 43846-0031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peaceful Mountain, Inc. for the product Cold Sore Rescue (NDC 43846-0031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
For temporary relief of symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.
For temporary relief of symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.
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.
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. For external use only. Consult a physician for use in children under 12 years of age.
Inactive Ingredients:
Aloe vera 10X Concentrate, Arnica Montana (Flower), Carbomer (Ultrez 21), Larrea tridentata (Leaf), Symphytum officinale (Leaf), Edetate disodium (EDTA), Lavandula angustifolia (Buds), Melissa officinalis (Leaf), Natural plant extract (Origanox WS), PEG-33, PEG-8 Dimethicone, PEG-14(Silsense Copolyol-1 Silicone), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen Plus), Phytolacca americana (Berries), Phytolacca americana (Root), Potassium sorbate, Purified Water, Sodium hydroxide (Solution), Hypericum perforatum (Aerial parts), Vitamin C (powder) [Ascorbic Acid], Vitamin E oil (Derived from Soy Bean), Salix alba (Bark), Achillea millefolium (Flower)
Questions:
888-303-3388 Mon-Fri 8 a.m.-5 p.m. CST
Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579
Package Label Display:
homeopathic relief
Temporary relief from cold sore and fever blisters symptoms.
Helps temporarily relief 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)
* Please review the disclaimer below.
