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 Jar
(click image for full-size original)
Shingles Rescue Jar
(click image for full-size original)
Shingles Rescue Carton
(click image for full-size original)
Shingles Rescue Carton
(click image for full-size original)
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.

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