Label: DERMA PAIN PLUS (croton tiglium, natrum muriaticum, plantago major, rhus toxicodendron, sarsaparilla- smilax regelii gel
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Contains inactivated NDC Code(s)
NDC Code(s): 43846-0080-1, 43846-0080-2 - Packager: Peaceful Mountain, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated April 16, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- INDICATIONS:
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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:
- DIRECTIONS:
- INDICATIONS:
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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:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
DERMA PAIN PLUS
croton tiglium, natrum muriaticum, plantago major, rhus toxicodendron, sarsaparilla (smilax regelii) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED 30 [hp_X] in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] in 1 g PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE 30 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 1 g SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT 30 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0080-2 1 in 1 CARTON 04/16/2021 1 NDC:43846-0080-1 40 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/16/2021 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0080) , api manufacture(43846-0080) , label(43846-0080) , pack(43846-0080)
