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

Acne Rescue by

Drug Labeling and Warnings

Acne Rescue by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

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

USES:

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

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

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 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 inflammation.**

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

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Juice (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 (Berry), Phytolacca Americana (Root), Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Hypericum Perforatum (Aerial Parts), Vitamin C (Powder) [Ascorbic Acid], Tocopherol [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 ι www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

acne

rescue

homeopathic

gel

Fast acting, natural

formula providing

temporary relief from

unsightly skin

conditions such as

acne and rosacea.

peaceful mountain

THE HEIGHT OF HEALTH

Net wt. 0.5 oz. (14 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
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)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0039-2	1 in 1 CARTON	12/29/2014
1	NDC: 43846-0039-1	14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/29/2014

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0039) , api manufacture(43846-0039) , label(43846-0039) , pack(43846-0039)