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NDC 30142-0978-33 Kroger Cool Mint Boost Mouth .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Kroger Cool Mint Boost Mouth .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Kroger Cool Mint Boost Mouth is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by The Kroger Company. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	30142-0978
Product ID	30142-978_b5204373-20bd-46c6-8ec3-7f99d745ebbe
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	Kroger Cool Mint Boost Mouth
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eucalyptol, Menthol, Methyl Salicylate, Thymol
Product Type	HUMAN OTC DRUG
Dosage Form	RINSE
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	The Kroger Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2022-12-31

Package

Package Images

NDC 30142-0978-33 (30142097833)

Pricing Information	N/A
NDC Package Code	30142-978-33
Billing NDC	30142097833
Package	1000 mL in 1 BOTTLE, PLASTIC (30142-978-33)
Marketing Start Date	2018-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 24ad0af2-8694-4bf1-8cfd-0b43ba4514b5 Details

Active ingredients

Eucalyptol 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Uses

helps control plaque that leads to gingivitis, an early form of gum disease.

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, increasing space between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately.

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

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.
cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

Water (Aqua), Alcohol (21.6%), Poloxamer 407, Flavor, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Sucralose, Green 3 (CI 42053).

Questions or comments?

1-800-632-6900

Label Copy

INGREDIENTS AND APPEARANCE

KROGER COOL MINT BOOST MOUTH

eucalyptol, menthol, methyl salicylate, thymol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-978
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	0.6 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)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-978-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/14/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/14/2018

Labeler - The Kroger Company (006999528)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(30142-978)

Revised: 2/2018

Document Id: b5204373-20bd-46c6-8ec3-7f99d745ebbe

Set id: 24ad0af2-8694-4bf1-8cfd-0b43ba4514b5

Version: 1

Effective Time: 20180215