DERMA PAIN PLUS- croton tiglium, natrum muriaticum, plantago major, rhus toxicodendron, sarsaparilla (smilax regelii) 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.

----------

DRUG FACTS:

ACTIVE INGREDIENTS:

(in gel): 0.20% of Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla 30X.

INDICATIONS:

May temporarily relieve stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

**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. • Do not use on broken or abraded skin.

Stop use and ask a doctor if • Rash develops  Condition worsens • Symptoms last more than 7 days. • Do not use if tamper evident 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 liberally as needed.

• Children under 12 years of age: Consult a doctor.

INDICATIONS:

May temporarily relieve stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

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

INACTIVE INGREDIENTS:

Purified Water, Poke (Berries) Phytolacca Americana, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-33, PEG-8 Dimethicone, PEG-14, Chaparral (Leaf) Larrea Tridentata, Comfrey (Leaf) Symphytum Officinale, St. John's Wart (Leaf, Flower, Stem) Hypericum Perforatum, Poke (Root) Phytolacca Americana, Arnica (Flower) Arnica Montana, Lemon Balm (Leaf) Melissa Officinalis, White Willow (Bark) Salix Alba, Yarrow (Flower) Achillea Millefolium, Sodium Hydroxide, English Lavender (Buds) Lavandula Angustifolia, Ascorbic Acid (Vitamin C), Tocopherols (Vitamin E), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.
Allergy Alert • Soy

QUESTIONS:

888-303-3388

Mon-Fri 8a.m-5p.m CST

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

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain
THE HEIGHT OF HEALTH
derma pain plus+
homeopathic gel
Net wt. 1.4 oz. (40 g)

Derma Pain Plus + LBL

Derma Pain Plus + CNT

DERMA PAIN PLUS 
croton tiglium, natrum muriaticum, plantago major, rhus toxicodendron, sarsaparilla (smilax regelii) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED30 [hp_X]  in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 g
PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE30 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 g
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT30 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)  
COMFREY LEAF (UNII: DG4F8T839X)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OREGANO (UNII: 0E5AT8T16U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0080-21 in 1 CARTON04/16/2021
1NDC:43846-0080-140 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/16/2021
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0080) , api manufacture(43846-0080) , label(43846-0080) , pack(43846-0080)

Revised: 4/2021
Document Id: e124082b-2f6f-465f-9b20-a04559e351f8
Set id: 6fa79c31-e48e-4c83-baa2-96cef22cfee1
Version: 1
Effective Time: 20210416
 
Peaceful Mountain, Inc.