CHAFE RESCUE- bryonia, arsenicum iodatum, baryta carbonica, alumina, calendula officinalis, sulphuricum acidum, symphytum officinale lotion 
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:

Bryonia (Alba) 1X, Arsenicum Iodatum 6X, Baryta Carbonica 8X, Alumina 12X, Calendula Officinalis 12X, Sulphuricum Acidum 12X, Symphytum Officinale 12X.

INDICATIONS:

For the temporary relief of discomfort from friction and chafing.**

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

WARNINGS:

​For exteral 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 - Do not apply to broken or abraded skin.

​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 liberally before and after physical exercise. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For the temporary relief of discomfort from friction and chafing.**

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

INACTIVE INGREDIENTS:

Allantoin, Aloe Vera Concentrate, Arnica Flower, Avocado oil, Calendula Flower, Carbomer, Comfrey Leaf, Edetate Disodium, Kukui Nut Oil, Lavender Buds, Macadamia Nut Oil, Natural Plant Extract, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Polysorbate 20, Potassium Sorbate, Purified Water, Rose Hips Seed Oil, Sodium Hydroxide, Soy Bean Seed Oil, Vitamin C, Vitamin E (Soy), White Willow Bark

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE DISPLAY LABEL:

peaceful mountain

THE HEIGHT OF HEALTH

chafe rescue

homeopathic lotion

formulated in boulder, co

​Net wt. 0.25 oz. (7 g)

chafe rescue foil pack

CHAFE RESCUE 
bryonia, arsenicum iodatum, baryta carbonica, alumina, calendula officinalis, sulphuricum acidum, symphytum officinale lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT1 [hp_X]  in 1 g
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)6 [hp_X]  in 1 g
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CATION8 [hp_X]  in 1 g
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE12 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]  in 1 g
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
COMFREY LEAF (UNII: DG4F8T839X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
MACADAMIA OIL (UNII: 515610SU8C)  
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)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SOYBEAN OIL (UNII: 241ATL177A)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0037-17 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/02/2014
Labeler - Peaceful Mountain, Inc (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0037) , api manufacture(43846-0037) , label(43846-0037) , pack(43846-0037)

Revised: 1/2014
Document Id: 8b66f47d-0914-4050-b230-e89d6e439e1d
Set id: e889739a-a85b-47ed-b44d-e5a30be0f45b
Version: 1
Effective Time: 20140102
 
Peaceful Mountain, Inc