NDC 43846-0080 Derma Pain Plus

Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Toxicodendron, Sarsaparilla (smilax Regelii)

NDC Product Code 43846-0080

NDC CODE: 43846-0080

Proprietary Name: Derma Pain Plus What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Toxicodendron, Sarsaparilla (smilax Regelii) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 43846 - Peaceful Mountain, Inc.

NDC 43846-0080-2

Package Description: 1 JAR in 1 CARTON > 40 g in 1 JAR (43846-0080-1)

NDC Product Information

Derma Pain Plus with NDC 43846-0080 is a a human over the counter drug product labeled by Peaceful Mountain, Inc.. The generic name of Derma Pain Plus is croton tiglium, natrum muriaticum, plantago major, rhus toxicodendron, sarsaparilla (smilax regelii). The product's dosage form is gel and is administered via topical form.

Labeler Name: Peaceful Mountain, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Derma Pain Plus Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CROTON TIGLIUM SEED 30 [hp_X]/g
  • SODIUM CHLORIDE 30 [hp_X]/g
  • PLANTAGO MAJOR WHOLE 30 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/g
  • SMILAX ORNATA ROOT 30 [hp_X]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Peaceful Mountain, Inc.
Labeler Code: 43846
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-16-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Derma Pain Plus Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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.

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:

888-303-3388Mon-Fri 8a.m-5p.m CSTDist. by Peaceful Mountain, Inc.  Woodbine, IA 51579www.peacefulmountain.com

Package Label Display:

Peaceful mountainTHE HEIGHT OF HEALTHderma pain plus+homeopathic gelNet wt. 1.4 oz. (40 g)

* Please review the disclaimer below.