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

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Drug Facts

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

Shingles Rescue Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H)	ALTHAEA OFFICINALIS ROOT	12 [hp_X] in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	12 [hp_X] in 1 g
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E)	CROTON TIGLIUM SEED	30 [hp_X] in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X] in 1 g
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	30 [hp_X] in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X] in 1 g
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	30 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0011-2	1 in 1 CARTON	03/19/2013	09/21/2022
1	NDC:43846-0011-1	40 g in 1 JAR; Type 0: Not a Combination Product

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

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

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

Revised: 6/2022

Document Id: ae027bbd-938c-492f-8dad-76d055b482a0

Set id: 90b9d0f1-62e3-4db4-b028-cf8c676c38ee

Version: 4

Effective Time: 20220615

Peaceful Mountain, Inc.