ANTISPETIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash 
H-E-B

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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

 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 unmder 12 years of age - consult a dentist or doctor

Inactive ingredients

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

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Adverse Reactions

MADE WITH PRIDE AND CARE FOR H-E-B

SAN ANTONIO, TX 78204

DSP-TN-1500   DSP-MO-34  SDS-TN-15012

Meets the TSA guidelines for carry-on luggage

Principal display panel

Compare to Listerine

H-E-B

Antiseptic

Fresh Green

Mint

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills Germs

Fights Bad Breath

Fights Plaque

Fights Gingivitis

Sealed with printed neckband for your protection

3.2 FL OZ (94 mL)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-072
Route of Administration ORAL DEA Schedule     
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:37808-072-12 1500 mL in 1 BOTTLE, PLASTIC
2 NDC:37808-072-86 1000 mL in 1 BOTTLE, PLASTIC
3 NDC:37808-072-77 500 mL in 1 BOTTLE, PLASTIC
4 NDC:37808-072-19 94 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 04/25/1995
Labeler - H-E-B (007924756)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(37808-072)

Revised: 11/2013
Document Id: c3ef3897-9cae-4900-afa2-2d59ee69060e
Set id: 21364d47-d026-4b48-8ece-ac44717f6522
Version: 1
Effective Time: 20131111
 
H-E-B