Label: CHAFE RESCUE- bryonia, arsenicum iodatum, baryta carbonica, alumina, calendula officinalis, sulphuricum acidum, symphytum officinale lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43846-0037-1 - 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 January 2, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- INDICATIONS:
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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:
- DIRECTIONS:
- INDICATIONS:
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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:
- PACKAGE DISPLAY LABEL:
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INGREDIENTS AND APPEARANCE
CHAFE RESCUE
bryonia, arsenicum iodatum, baryta carbonica, alumina, calendula officinalis, sulphuricum acidum, symphytum officinale lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 1 [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 CATION 8 [hp_X] in 1 g ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE 12 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 1 g SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID 12 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0037-1 7 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/02/2014 Labeler - Peaceful Mountain, Inc (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0037) , api manufacture(43846-0037) , label(43846-0037) , pack(43846-0037)