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NDC 59883-0500-01 OralProCare Medicated Lip Treatment 0.6 g/6g Details

OralProCare Medicated Lip Treatment 0.6 g/6g

OralProCare Medicated Lip Treatment is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Den-Mat Holdings, LLC. The primary component is ALCOHOL.

Product Information

NDC	59883-0500
Product ID	59883-500_d5f731b2-6a6b-b51b-e053-2995a90ad4f8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	OralProCare Medicated Lip Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	Medicated Lip Treatment
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.6
Active Ingredient Units	g/6g
Substance Name	ALCOHOL
Labeler Name	Den-Mat Holdings, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 59883-0500-01 (59883050001)

Pricing Information	N/A
NDC Package Code	59883-500-01
Billing NDC	59883050001
Package	1 TUBE, WITH APPLICATOR in 1 CARTON (59883-500-01) / 9.9 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date	2022-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d5f731b2-6a6a-b51b-e053-2995a90ad4f8 Details

Drug Facts

Active Ingredients

Ethyl alcohol 6.0%

Purpose

Antibacterial

Uses

Aids in the treatment of cold sores

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/25/2022

Labeler - Den-Mat Holdings, LLC (809857704)

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

Revised: 1/2022

Document Id: d5f731b2-6a6b-b51b-e053-2995a90ad4f8

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

Version: 1

Effective Time: 20220119

Search by Drug Name or NDC

NDC 59883-0500-01 OralProCare Medicated Lip Treatment 0.6 g/6g Details

OralProCare Medicated Lip Treatment 0.6 g/6g

Product Information

Package

Package Images

NDC 59883-0500-01 (59883050001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d5f731b2-6a6a-b51b-e053-2995a90ad4f8 Details

Drug Facts

Active Ingredients

Purpose

Uses

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other Information

Inactive Ingredient Section

Questions or Comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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