Label: SCAR REMOVER- arnica montana, calcarea fluorica, calcarea phosphorica, calendula officinalis, graphites, hydrofluoricum acidum, phytolacca decandra, sabina, silicea, thiosinaminum, thuja occidentalis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0816-3 - Packager: King Bio 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 October 21, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Drug Facts
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HPUS active ingredients: Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum, Thuja occidentalis. Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.
- INDICATIONS & USAGE
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WARNINGS
Warnings
- Stop use and ask your doctor if symptoms persist or worsen.
- If pregnant or breast-feeding, ask a healthcare professional before use.
- Keep out of reach of children.
- For external use only.
- Avoid using near eyes or mouth.
- If swallowed, get medical help or contact a Poison Control Center immediately.
- Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.
- May stain clothing.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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PURPOSE
Drug Facts
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HPUS active ingredients Purpose
Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.
Arnica montana......................................................tissue degradation
Calcarea fluorica.....................................................adhesions
Calcarea phosphorica...............................................scars
Calendula officinalis.................................................scar formation
Graphites...............................................................scar tissue
Hydrofluoricum acidum............................................scar tissue
Phytolacca decandra................................................papular lesions
Sabina...................................................................keloids
Silicea....................................................................keloids, scar tissue
Thiosinaminum........................................................adhesions
Thuja occidentalis....................................................ulcerated skin
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SCAR REMOVER
arnica montana, calcarea fluorica, calcarea phosphorica, calendula officinalis, graphites, hydrofluoricum acidum, phytolacca decandra, sabina, silicea, thiosinaminum, thuja occidentalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0816 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 10 [hp_X] in 15 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X] in 15 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 10 [hp_X] in 15 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 10 [hp_X] in 15 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 10 [hp_X] in 15 mL HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 10 [hp_X] in 15 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 10 [hp_X] in 15 mL JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG 10 [hp_X] in 15 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 15 mL ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA 10 [hp_X] in 15 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X] in 15 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ARGAN OIL (UNII: 4V59G5UW9X) CASTOR OIL (UNII: D5340Y2I9G) FRANKINCENSE OIL (UNII: 67ZYA5T02K) HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K) LAVENDER OIL (UNII: ZBP1YXW0H8) MYRRH OIL (UNII: H74221J5J4) OREGANO LEAF OIL (UNII: 7D0CGR40U1) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0816-3 1 in 1 CARTON 1 15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/18/2014 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(57955-0816)
