ACNE RESCUE- borax, carbo vegetabilis, carboneum sulphuratum, causticum, natrum muriaticum, silicea 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

Borax 30X, Carbo Vegetabilis 12X, Carboneum Sulphuratum 12X, Causticum 12X, Natrum Muriaticum 30X, Silicea 30X

INDICATIONS:

Temporarily relieves symptoms associated with acne: pimples, redness, itching, inflamation.**

**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 helpor 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.

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 twice daily over affected area. Consult a physician for use in children under 12 years of age.

INDICATIONS:

Temporarily relieves symptoms associated with acne: pimples, redness, itching, inflamation.**

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

INACTIVE INGREDIENTS:

Aloe Vera, Arnica (Flower), Carbomer, Chaparral (leaf) Comfrey (leaf), Edetate Disodium, Lavender (buds), Lemon Balm, PEG 33 , PEG 8 Dimethicone, PEG 14, Poke (Berry), Poke (root), Potassium Sorbate, Purified Water, Sodium Hydroxide, St. John's Wort, Vitamin C, Vitamin E, White Willow (bark), Yarrow (flower).

QUESTIONS:

Dist. By Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

ACNE RESCUE

Net wt. 025 oz (7g)

ACNE RESCUE

ACNE RESCUE
borax, carbo vegetabilis, carboneum sulphuratum, causticum, natrum muriaticum, silicea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43846-0040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	30 [hp_X] in 1 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X] in 1 g
CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8)	CARBON DISULFIDE	12 [hp_X] in 1 g
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X] in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X] in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
LEMON BALM OIL (UNII: MJ76269K9S)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ST. JOHN'S WORT (UNII: UFH8805FKA)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0040-1	7 g in 1 PACKET; Type 0: Not a Combination Product	07/10/2014	07/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/10/2014	07/03/2022

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0040) , api manufacture(43846-0040) , label(43846-0040) , pack(43846-0040)

Revised: 12/2021

Document Id: b7b32f78-5e78-4936-8fab-6dbe7a1495f4

Set id: 7a7ef7f7-c788-4056-ba92-17616baaa1cb

Version: 3

Effective Time: 20211214

Peaceful Mountain, Inc.