BITE, BUMP AND RASH RELIEF- apis mellifica, astacus fluviatilis, belladonna, calcarea carbonica, gelsemium sempervirens, mezereum, rhus tox 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:

(in gel): 1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.

INDICATIONS:

May temporarily relieve itching, insect bites, poison ivy, rashes, eczema, hives, inflammation and irritated red skin.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 • Conditions worsens • Symptoms last more than 7 days

Do not use if safety seal is broken or missing.

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 at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

May temporarily relieve itching, insect bites, poison ivy, rashes, eczema, hives, inflammation and irritated red skin.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Juice, Purified Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide (Solution).

QUESTIONS:

Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579

888-303-3388
www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

bite, bump and

rash relief

homeopathic

anti-itch gel

paraben-free

unscented • non-greasy

No menthol • no animal testing

Net wt. 2 oz. (57 g)

Bite, Bump and Rash Relief

BITE, BUMP AND RASH RELIEF 
apis mellifica, astacus fluviatilis, belladonna, calcarea carbonica, gelsemium sempervirens, mezereum, rhus tox gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK12 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 g
ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ) ASTACUS ASTACUS15 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0079-157 g in 1 TUBE; Type 0: Not a Combination Product01/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/10/2019
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0079) , api manufacture(43846-0079) , label(43846-0079) , pack(43846-0079)

Revised: 1/2019
Document Id: 62504221-081d-488c-a478-95a59f401192
Set id: e158a743-160f-446e-a0ea-a2ce566d866f
Version: 1
Effective Time: 20190110
 
Peaceful Mountain, Inc.