FDA.reportPublic FDA data

OralProCare Medicated Lip Treatment

Manufacturer
Den-Mat Holdings, LLC
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:11:51

Label at a glance#

ProductOralProCare Medicated Lip Treatment
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Aids in the treatment of cold sores

Dosage and administration

Users 18 and older: ■ For external use only. ■ Wash hands before and after use. ■ Place a small amount on fingertip and rub gently but completely onto cold sore up to 5 times per day for up to 7 days. ■ Avoid contact with eyes. ■ Do not swallow. Children under 18 – Consult your doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 6.0%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Aids in the treatment of cold sores

WARNINGS SECTION

Chlorhexidine can cause a rare but serious allergic reaction. Symptoms may include: hives, skin rash; wheezing, difficulty breathing; cold sweats, severe dizziness; swelling of face, lips, tongue, or throat. If an allergic reaction occurs, stop use and seek medical attention

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep of reach of Children

Directions

DOSAGE & ADMINISTRATION SECTION


Users 18 and older:
■ For external use only.
■ Wash hands before and after use.
■ Place a small amount on fingertip and rub gently but completely onto cold sore up to 5 times per day for up to
7 days.
■ Avoid contact with eyes.
■ Do not swallow.
Children under 18 – Consult your doctor

Other Information

OTHER SAFETY INFORMATION

Do not use if tamper-proof seals on carton are broken or missing.

Inactive Ingredient Section

Chlorhexidine gluconate, Hydroxyethyl cellulose, Peppermint oil, Polysorbate 40 NF, Purified water, Xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-752-2564

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-50059883-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
POLYSORBATE 40STI11B5A2XIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
XANTHAN GUMTTV12P4NEEIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
PEPPERMINT OILAV092KU4JHIACT

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
0daa8612-d9e0-87f2-e063-6294a90a65afd5f731b2-6a6a-b51b-e053-2995a90ad4f82023-12-29WarningsExact identifier
spl set id: d5f731b2-6a6a-b51b-e053-2995a90ad4f8

Reported adverse events (FAERS/openFDA)#

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