FDA.reportPublic FDA data

PROVON Perineal Skin Prot

Manufacturer
GOJO Industries, Inc.
Effective date
2010-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:26:49

Label at a glance#

ProductPROVON Perineal Skin Prot with 99 Petrolatum
Active ingredientPETROLATUM
Label structure7 sections

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 99%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped, or cracked skin

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product • do not get into eyes

OTC - ASK DOCTOR SECTION

See a doctor if condition lasts more than 7 days

OTC - DO NOT USE SECTION

Do not use on • deep or puncture wounds • animal bites • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitan Oleate, Tocopheryl Acetate, Fragrance (Parfum), Green 6 (CI 61565)

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21749-442-022023-08-01C16284748780-10191ceaa-6f48-198a-e063-dbdaa90aec3ePROVON Perineal Skin Protectant
21749-442-052023-08-01C16284748780-10191ceaa-6f48-198a-e063-dbdaa90aec3ePROVON Perineal Skin Protectant
21749-442-072023-08-01C16284748780-10191ceaa-6f48-198a-e063-dbdaa90aec3ePROVON Perineal Skin Protectant
21749-442-022023-07-28C16284748780-10191ceaa-6f48-198a-e063-dbdaa90aec3ePROVON Perineal Skin Protectant
21749-442-052023-07-28C16284748780-10191ceaa-6f48-198a-e063-dbdaa90aec3ePROVON Perineal Skin Protectant
21749-442-072023-07-28C16284748780-10191ceaa-6f48-198a-e063-dbdaa90aec3ePROVON Perineal Skin Protectant

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-44221749-442-02, 21749-442-05, 21749-442-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C GREEN NO. 64QP5U84YF7IACT

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
93edb7b7-6750-49a1-9be3-a721ec2d2cd1b8a45498-8dda-47f8-971a-feb785de6cdb2024-03-21WarningsExact identifier
spl set id: b8a45498-8dda-47f8-971a-feb785de6cdb

Reported adverse events (FAERS/openFDA)#

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