ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antispetic by

Drug Labeling and Warnings

Antispetic by is a Otc medication manufactured, distributed, or labeled by Supervalu INC, Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help control plaque that leads to gingivitis

Warnings

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.

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 (59⁰ - 77⁰ F)

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.

ADA Council on Scientific Affairs

The ADA Council on Scientific Affairs' Acceptance of Equaline Spring Mint antiseptic Mouth rinse is based on its finding tha the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

This product is not manufatured or distriubted by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Adverse Reactions

DISTRIBUTED BY SUPERVALU INC

EDEN PRAIRIE, MN 55344 USA

Contact us at 1-877-932-7948

or www.supervalu-ourownbrands.com

072.002/072AL

principal display panel

compare to

Listerine FreshBurst

Antiseptic Mouthwash

active ingredient

EQUALINE

antispetic

mouthrinse

antigingivitis/antiplaque

ADA

Accepted

Amnerican

Dental

Association

Kills germs that cause bad breath, plaque and gingivitis gum disease

spring mint

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-072
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 (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

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 CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2004
2	NDC: 41163-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2004
3	NDC: 41163-072-13	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2004
4	NDC: 41163-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/28/2004

Labeler - Supervalu INC (006961411)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(41163-072)