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NDC 63824-0790-80 Cepacol 0.05 g/100mL Details

Cepacol 0.05 g/100mL

Cepacol is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is CETYLPYRIDINIUM CHLORIDE.

Product Information

NDC	63824-0790
Product ID	63824-790_eb04d546-a26e-4a25-8b51-a58e3c605a20
Associated GPIs	88300009100910
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	Cepacol
Proprietary Name Suffix	Antibacterial
Non-Proprietary Name	Cetylpyridinium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	0.05
Active Ingredient Units	g/100mL
Substance Name	CETYLPYRIDINIUM CHLORIDE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63824-0790-80 (63824079080)

Pricing Information	N/A
NDC Package Code	63824-790-80
Billing NDC	63824079080
Package	1 BOTTLE in 1 CARTON (63824-790-80) / 710 mL in 1 BOTTLE
Marketing Start Date	2011-06-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7c19eba6-3ebd-497f-9066-6152b72eafdd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Uses

helps prevent and reduce plaque that leads to:

gingivitis, an early form of gum disease
bleeding gums

Warnings

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of the reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse
children 6 years to under 12 years of age: supervise use
children under 6 years of age: do not use.

Other Information

this rinse is not intended to replace brushing or flossing
store at room temperature 20-25°C (68-77°F)
protect from humidity

Inactive ingredients

purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

Questions?

1-888-963-3382 You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

NDC 63824-790-80

Cēpacol®

ANTIBACTERIAL*

MULTI-PROTECTION MOUTHWASH

CPC–Antigingivitis/Antiplaque Oral Rinse

*Kills Germs That Cause Bad Breath

Reduces Plaque
Freshens Breath

#1 BRAND IN HOSPITALS

TO OPEN: Squeeze both raised finger pads

on cap and continue to squeeze while turning.

TO CLOSE: Turn cap until it locks completely.

24 FL. OZ. (710 mL)

0336220

062111

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

INGREDIENTS AND APPEARANCE

CEPACOL ANTIBACTERIAL

cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-790
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetylpyridinium chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium chloride	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CINNAMON OIL (UNII: E5GY4I6YCZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63824-790-80	1 in 1 CARTON	06/22/2011
1		710 mL in 1 BOTTLE; 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	part356	06/22/2011

Labeler - RB Health (US) LLC (081049410)

Revised: 6/2022

Document Id: eb04d546-a26e-4a25-8b51-a58e3c605a20

Set id: 7c19eba6-3ebd-497f-9066-6152b72eafdd

Version: 6

Effective Time: 20220622

Search by Drug Name or NDC

NDC 63824-0790-80 Cepacol 0.05 g/100mL Details

Cepacol 0.05 g/100mL

Product Information

Package

Package Images

NDC 63824-0790-80 (63824079080)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7c19eba6-3ebd-497f-9066-6152b72eafdd Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a dentist if

Directions

Other Information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

INGREDIENTS AND APPEARANCE

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