FDA.reportPublic FDA data

Protocoxil

Manufacturer
Bio Ekuiliber LLC
Effective date
2020-11-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:34:35

Label at a glance#

ProductProtocoxil
Active ingredientBENZYL ALCOHOL
Label structure8 sections

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzyl alcohol 10%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • if symptoms persist for more than 7 days
  • if symptoms clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aqua (deionized water), disodium EDTA, glycerin, isopropyl alcohol, pinus pinaster bark extract, piper nigrum (pepper) seed oil, tocopheryl acetate, triethanolamine

Questions or comments?

OTC - QUESTIONS SECTION

Call 786-230-6366 Monday to Friday, 9 am to 5 pm EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

v1v1v2v2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71416-001-002022-01-28C16284748780-1d6a99b39-9991-a426-e053-dadaa90af4c2Protocoxil
71416-001-012022-01-28C16284748780-1d6a99b39-9991-a426-e053-dadaa90af4c2Protocoxil

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71416-00171416-001-00, 71416-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MARITIME PINE50JZ5Z98QYIACT
WHITE PEPPER OIL2AM83DL9FVIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
BENZYL ALCOHOLLKG8494WBHACTIB

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
b517b1db-6ee9-116a-e053-2995a90a71db0612d4de-1c47-47fe-9a90-9ff6a8f3db0e2020-11-27WarningsExact identifier
spl id: b517b1db-6ee9-116a-e053-2995a90a71db
spl set id: 0612d4de-1c47-47fe-9a90-9ff6a8f3db0e

Reported adverse events (FAERS/openFDA)#

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