BEING WELL ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Being Well Antiseptic by

Drug Labeling and Warnings

Being Well Antiseptic by is a Otc medication manufactured, distributed, or labeled by Save-A-Lot Food Stores, LTD, Vi-Jon. 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

antigingivitus, antiplaque

Use

   helps control plaque that leads to gingivitis

Warnings

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 (59° -77° F)

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

"The ADA Council on Scientific Affairs" Acceptance of Being Well Spring Mint Antisetpic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed."

*This product is not manufactured or distributed by JOHNSON & JOHNSON HEALTHCARE PRODUCTS, distributor of Freshburst LISTERINE Antiseptic Mouthwash.

Sealed with printed neck band for your protection

DISTRIBUTED BY: SAVE-A-LOT STORES, LTD.

EARTH CITY, MO 63045

savealot.com

Savealot promise 100% money back guarantee

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Principal display panel

Compare to Freshburst Listerine Antiseptic Mouthwash*

ANTISEPTIC MOUTHRINSE

Antigingivitis/Antiplaque

Helps remove germs that cause plaque, gingivitis and bad breath

Being Well

Spring Mint

ADA Accepted American Dental Association

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

BEING WELL ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46994-072
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: 46994-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/03/2014

Labeler - Save-A-Lot Food Stores, LTD (095484572)

Registrant - Vi-Jon (790752542)