ANTISEPTIC LIL DRUG STORE PRODUCTS- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Eucalyptol 0.092%, Menthol 0.042%	Antigingivitis, Antiplaque
Methyl salicylate 0.060%, Thymol 0.064%	Antigingivitis, Antiplaque

Use

Helps reduce plaque that leads to

• gingivitis
• bleeding gums

Warnings

Stop use and see your dentist immediately 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 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 swallowed, 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 teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
• children 6 to 12 years of age: supervise use
• children under 6 years of age: do not use

Other information

• not intended to replace brushing or flossing
• store at room temperature (59°-77°F).
• cold weather may cloud this product, but will not affect its antiseptic properties.

Inactive ingredients

alcohol (21.6%), benzoic acid, flavor, green 3, polaxamer 407, sodium benzoate, sodium saccharin, sorbitol, water

SPL UNCLASSIFIED SECTION

Distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active Ingredients
in Listerine® Cool Mint®*

Blue Mint

Antiseptic
Mouthwash
Antigingivitis/Antiplaque

Helps remove germs that cause
Bad Breath Plaque Gingivitis

8.5 FL OZ (251 mL)

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

ANTISEPTIC   LIL DRUG STORE PRODUCTS
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6861
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK)	Eucalyptol	0.92 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	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

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6861-4	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	12/01/2014

Labeler - Lil' Drug Store Products, Inc (093103646)