Shingles Rescue: Homeopathic Product Information

SHINGLES RESCUE- althaea officinalis root, calendula officinalis flowering top, croton tiglium seed, sodium chloride, plantago major, toxicodendron pubescens leaf and smilax ornata root 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:

Althaea Officinalis 12X, Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Toxicodendron 30X, Sarsaparilla 30X

USES:

For temporary relief of stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

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

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

When using this product — Do not get into eyes.

Stop use and ask a doctor if — Condition worsens Symptoms last more than 7 days.

DIRECTIONS:

Apply at least 3 times daily over affected area. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Aloe Vera 10X Concentrate, Carbomer (Ultrez 21), Larrea Tridentata (Leaf), Symphytum Officinale (Leaf), Edetate Disodium (EDTA), 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), Potassium Sorbate, Purified Water, Sodium Hydroxide Solution, Hypericum Perforatum (Aerial Parts), Vitamin C (Powder)[Ascorbic Acid], Vitamin E Oil (Derived from Soy Bean)

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.

USES:

For temporary relief of stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

QUESTIONS:

For temporary relief of stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

shingles rescue

homeopathic gel

sensitive skin

Net wt. 1.4 oz. (40 g)

SHINGLES RESCUE althaea officinalis, calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus toxicodendron gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTHAEA OFFICINALIS ROOT (ALTHAEA OFFICINALIS ROOT) ALTHAEA OFFICINALIS ROOT 12 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 1 g CROTON TIGLIUM SEED (CROTON TIGLIUM SEED) CROTON TIGLIUM SEED 30 [hp_X] in 1 g SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X] in 1 g PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 30 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 1 g SMILAX ORNATA ROOT (SARSAPARILLA) SMILAX ORNATA ROOT 30 [hp_X] in 1 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) LARREA TRIDENTATA TOP COMFREY LEAF EDETATE DISODIUM OREGANO POLYETHYLENE GLYCOL 1500 PEG-8 DIMETHICONE POLYETHYLENE GLYCOL 700 PHENOXYETHANOL CAPRYLYL GLYCOL SORBIC ACID PHYTOLACCA AMERICANA FRUIT POTASSIUM SORBATE WATER SODIUM HYDROXIDE HYPERICUM PERFORATUM ASCORBIC ACID .ALPHA.-TOCOPHEROL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43846-0011-2 1 JAR in 1 CARTON contains a JAR (43846-0011-1) 1 NDC:43846-0011-1 40 g in 1 JAR This package is contained within the CARTON (43846-0011-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/19/2013 09/21/2022

Labeler — Peaceful Mountain, Inc. (078430707)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (43846-0011), api manufacture (43846-0011), label (43846-0011), pack (43846-0011)

Revised: 06/2022 Peaceful Mountain, Inc.