FDA.reportPublic FDA data

Scar Freee

Manufacturer
King Bio Inc.
Effective date
2012-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:02

Label at a glance#

ProductScar Freee
Active ingredientARNICA MONTANA, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CALENDULA OFFICINALIS FLOWERING TOP, GRAPHITE, HYDROFLUORIC ACID, PHYTOLACCA AMERICANA ROOT, JUNIPERUS SABINA LEAFY TWIG, ALLYLTHIOUREA, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Dosage and administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adult Dose 3 pump sprays Children 2-12 years 2 pump sprays

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum and Thuja occidentalis.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X and LM1 potencies.

Purpose

OTC - PURPOSE SECTION


Uses assists in the prevention and reduction of:

  • scar tissue
  • tendencies toward scarring
  • adhesions after operations, injuries or infections

Dosage and administration

DOSAGE & ADMINISTRATION SECTION


Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2-12 years 2 pump sprays

Warnings

WARNINGS SECTION


If symptoms persist or worsen, consult a physician. If pregnant or nursing, take only on advice of healthcare professional. Keep out of reach of children.

Other Tamper resistant for your protection. Use only if safety seal is intact.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Purpose

INDICATIONS & USAGE SECTION

Uses assists in the prevention and reduction of: scar tissue, tendencies toward scarring, adhesions after operations, injuries or infections.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of label
Image of label

 
King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Question? Call 800.543.3245

www.kingbio.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5087-22020-01-31C16284748780-19d75b9cf-e3a2-f424-e053-dadaa90a57ceScar Freee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5087-2Scar Freee59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5087SCAR FREEE (ARNICA MONTANA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, GRAPHITES, HYDROFLUORICUM ACIDUM, PHYTOLACCA DECANDRA, SABINA, SILICEA, THIOSINAMINUM AND THUJA OCCIDENTALIS) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20121012_f001ec12-25c5-45a0-9a78-4c6199b9cd55.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLYLTHIOUREAACTIVE INGREDIENT706IDJ14B71
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
GRAPHITEACTIVE INGREDIENT4QQN74LH4O1
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ1
JUNIPERUS SABINA LEAFY TWIGACTIVE INGREDIENTZ5BEX9K2G11
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z281
ALLYLTHIOUREAACTIVE MOIETY706IDJ14B71
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
GRAPHITEACTIVE MOIETY4QQN74LH4O1
HYDROFLUORIC ACIDACTIVE MOIETYRGL5YE86CZ1
JUNIPERUS SABINA LEAFY TWIGACTIVE MOIETYZ5BEX9K2G11
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-508757955-5087-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
GRAPHITE4QQN74LH4OACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
ALLYLTHIOUREA706IDJ14B7ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
78a5f2fb-e4de-4204-84c3-c274d158e147f001ec12-25c5-45a0-9a78-4c6199b9cd552012-10-11WarningsExact identifier
spl id: 78a5f2fb-e4de-4204-84c3-c274d158e147
spl set id: f001ec12-25c5-45a0-9a78-4c6199b9cd55

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.