OralProCare Medicated Lip Treatment by Den-Mat Holdings, LLC

OralProCare Medicated Lip Treatment by

Drug Labeling and Warnings

OralProCare Medicated Lip Treatment by is a Otc medication manufactured, distributed, or labeled by Den-Mat Holdings, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORALPROCARE MEDICATED LIP TREATMENT- medicated lip treatment gel 
Den-Mat Holdings, LLC

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Drug Facts

Active Ingredients

Ethyl alcohol 6.0%

Purpose

Antibacterial

Uses

Aids in the treatment of cold sores

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

Keep of reach of Children

Directions

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

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?

Call 1-800-752-2564

ORALPROCARE MEDICATED LIP TREATMENT 
medicated lip treatment gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.6 g  in 6 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
POLYSORBATE 40 (UNII: STI11B5A2X)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-500-01	1 in 1 CARTON	01/25/2022	12/29/2023
1		9.9 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/25/2022	12/29/2023

Labeler - Den-Mat Holdings, LLC (809857704)

Establishment
Name	Address	ID/FEI	Business Operations
Den-Mat Holdings, LLC		809857704	label(59883-500) , manufacture(59883-500) , pack(59883-500)

Revised: 12/2023

Document Id: 0daa8612-d9e0-87f2-e063-6294a90a65af

34390-5

Set id: d5f731b2-6a6a-b51b-e053-2995a90ad4f8

Version: 2

Effective Time: 20231229