FDA.reportPublic FDA data

Ouch

Manufacturer
VIATREXX BIO INCORPORATED | Les Importations Herbasante Inc
Effective date
2022-11-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:18:43

Label at a glance#

ProductOuch
Active ingredientANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT, APOMORPHINE, ARNICA MONTANA, METENKEFALIN, BRYONIA ALBA ROOT, HYPERICUM PERFORATUM, BOS TAURUS HYPOTHALAMUS, SUS SCROFA HYPOTHALAMUS, BOS TAURUS LIMBIC SYSTEM, SUS SCROFA LIMBIC SYSTEM, BOS TAURUS NERVE, SUS SCROFA NERVE, BOS TAURUS PITUITARY GLAND, SUS SCROFA PITUITARY GLAND
Label structure10 sections

Indications and uses

To help reduce inflammation and reduce pain

Dosage and administration

1-5 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

Storage and handling

Normal storage use. Do not use if tamper-evident seal is broken or removed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Anti-Interleukin-1 9X 30K, Apomorphine 8X  30K, Arnica montana 3X, Beta endorphin 9X 30K, Bryonia 4X, Hypericum perforatum 3X, Hypothalamus 5X, Limbic System 6X 200K, Nerve 6X 30K, Pituitary gland 6X

Purpose

OTC - PURPOSE SECTION

Anti-Interleukin-1Anti-inflammation
ApomorphinePain relief
Arnica montanaInjury relief
Beta endorphinPain relief
BryoniaDrainage
Hypericum perforatumNeurological support
HypothalamusRegeneration
Limbic SystemRegeneration
NerveRegeneration
Pituitary glandRegeneration

Uses

INDICATIONS & USAGE SECTION

To help reduce inflammation and reduce pain

Warnings

WARNINGS SECTION

Stop use and ask a health care practitioner if symptoms persist for more than 5 days or worsen. If pregnant or breastfeeding, ask a health care practitioner before use.

 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

1-5 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

Other Ingredients

INACTIVE INGREDIENT SECTION

Alcohol and Water

Other Information

STORAGE AND HANDLING SECTION

Normal storage use.

Do not use if tamper-evident seal is broken or removed.

Questions

OTC - QUESTIONS SECTION

info@viatrexx.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ITEM: VPC0500

NDC 63776-402-15

Homeopathic remedy

Ouch

• To help reduce inflammation and reduce pain

Oral spray
50ml 1.7 oz

Viatrexx™ Bio Incorporated

Manufactured by Viatrexx
www.viatrexx.com
Newark, DE 19713

Ouch Box
Ouch Box

Ouch

50 mL
1.7 oz

Viatrexx™ Bio Incorporated

ITEM: VPC0500
NDC: 63776-402-15

INDICATIONS:
To help reduce inflammation and reduce pain

DIRECTIONS:
1-5 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

Mfg. for
Viatrexx Bio Incorporated.
www.viatrexx.com
Newark, DE 19713

Ingredients
Ingredients

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cacec2b-1363-4e94-885c-4189d5e7208aProduct name120251117
d7fea1a2-3459-27e8-1231-1b79988f4937Product name220221207
3a53909e-cbfb-4956-984e-a33101906fd9Product name120201021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63776-402-152024-01-30C16284748780-11030e364-ff73-111a-e063-dadaa90a10e2Ouch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63776-402-15Ouch1 in 1 BOXSPRAY13
63776-402-15Ouch50 mL in 1 BOTTLE, SPRAYSPRAY503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63776-402OUCH (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT, APOMORPHINE, ARNICA MONTANA, METENKEFALIN, BRYONIA ALBA ROOT, HYPERICUM PERFORATUM, BOS TAURUS HYPOTHALAMUS, SUS SCROFA HYPOTHALAMUS, BOS TAURUS LIMBIC SYSTEM, SUS SCROFA LIMBIC SYSTEM, BOS TAURUS NERVE, SUS SCROFA NERVE, BOS TAURUS PITUITARY GLAND, SUS SCROFA PITUITARY GLAND) SPRAY [VIATREXX BIO INCORPORATED]3Legacy NDC, 2 package rows20221202_8bbbc44e-b9c3-455a-a4d8-3a5f2beb5bdf.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63776-40263776-402-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITML4QRZ1HCLACTIB
APOMORPHINEN21FAR7B4SACTIB
ARNICA MONTANAO80TY208ZWACTIB
METENKEFALIN9JEZ9OD3ASACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
SUS SCROFA HYPOTHALAMUSN6R0856Z79ACTIB
BOS TAURUS LIMBIC SYSTEM28WIH9KKYGACTIB
SUS SCROFA LIMBIC SYSTEMF7PEN4AZI7ACTIB
BOS TAURUS NERVE28G2U3MQJKACTIB
SUS SCROFA NERVEJXV50I6ZHKACTIB
BOS TAURUS PITUITARY GLAND7JM57I419KACTIB
SUS SCROFA PITUITARY GLANDE8S87O660TACTIB

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
eeb57829-dc7d-6e70-e053-2995a90a7de88bbbc44e-b9c3-455a-a4d8-3a5f2beb5bdf2022-11-30WarningsExact identifier
spl id: eeb57829-dc7d-6e70-e053-2995a90a7de8
spl set id: 8bbbc44e-b9c3-455a-a4d8-3a5f2beb5bdf

Reported adverse events (FAERS/openFDA)#

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