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.

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)

Acne Rescue tube

Acne Rescue carton

Acne Rescue tube

ACNE RESCUE 
borax, carbo vegetabilis, carboneum sulphuratum, causticum, natrum muriaticum, silicea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE30 [hp_X]  in 1 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 g
CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE12 [hp_X]  in 1 g
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM12 [hp_X]  in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0039-21 in 1 CARTON12/29/2014
1NDC:43846-0039-114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/29/2014
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0039) , api manufacture(43846-0039) , label(43846-0039) , pack(43846-0039)

Revised: 1/2018
Document Id: 4301f4e3-3dde-4df2-b3bf-0ce5f1ab5d86
Set id: 0f4d02cb-dc59-4fe4-b6d1-e9a7a81139a9
Version: 2
Effective Time: 20180124
 
Peaceful Mountain, Inc.