ANTISPETIC- eucalyptol, menthol, methyl salicylate, 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

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 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

Questions

Call 1-888-593-0593

ADA Council Statement

"The ADA Council on Scientific Affairs Acceptance of HEB Fresh Green Mint Antiseptic Mouthwash 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."

Disclaimer

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

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR  PROTECTION

Adverse Reactions

MADE WITH PRIDE ANC ARE FOR H-E-B

SAN ANTONIO, TX 78204

Principal Display Panel

Compare to Listerine

H-E-B

Fresh Green Mint

ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

MOUTHWASH

ADA

Accepted

American

Dental Association

50.7 FL OZ (1.58 QT) 1.5 L

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
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; Type 0: Not a Combination Product 04/25/1995
2 NDC:37808-072-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/25/1995
3 NDC:37808-072-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/25/1995
4 NDC:37808-072-19 94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/25/1995
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: 7/2016
Document Id: a42bbaa3-8b5c-418d-8015-bfe794052aca
Set id: 21364d47-d026-4b48-8ece-ac44717f6522
Version: 2
Effective Time: 20160725
 
H-E-B