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NDC 70000-0528-01 Antiseptic .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Antiseptic .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Antiseptic is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba Leader. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	70000-0528
Product ID	70000-0528_18fd20ea-9e63-4930-949b-c5d334dd4b87
Associated GPIs	88300000000900
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	Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eucalyptol, Menthol, Methyl Salicylate, Thymol
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	.92; .42; .6; .64
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Labeler Name	Cardinal Health, 110 dba Leader
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 70000-0528-01 (70000052801)

Pricing Information	N/A
NDC Package Code	70000-0528-1
Billing NDC	70000052801
Package	500 mL in 1 BOTTLE, PLASTIC (70000-0528-1)
Marketing Start Date	1997-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d176eebb-4870-4206-a52e-f581ecaff400 Details

Active ingredient

Eucalyptol 0.092%, Menthol 0.042%

Methyl salicylate 0.060%, Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Do not use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Poison Control Center 1-800-222-1222 right away.

directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

this rinse is not intended to replace brushing or flossing

other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

inactive ingredients

water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, Flavor, green 3

disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine registered trademark of Listerine Cool Mint.

2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the propertyh of their respective owners.

100% Money Back Guarantee

Return to place of purchase if not satisfied.

DISTRBUTED BY CARDINAL HEALTH

DUBLIN, OHIO, 43017

www.myleader.com

1-800-200-6313

principal display panel

LEADER

NDC 70000-0528-1

Antiseptic

Mothrinse

Antigingivitis/Antiplaque

Blue Mint

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis Gum Disease

COMPARE TO

LISTERINE

COOL MINT

active ingredients

100% Money

Back Guarantee

500 mL (16.9 FL OZ)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

INGREDIENTS AND APPEARANCE

ANTISEPTIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0528
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0528-1	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/1997

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	06/15/1997

Labeler - Cardinal Health, 110 dba Leader (063997360)

Revised: 5/2022

Document Id: 18fd20ea-9e63-4930-949b-c5d334dd4b87

Set id: d176eebb-4870-4206-a52e-f581ecaff400

Version: 16

Effective Time: 20220513