Equate 072.003/072al Rev 2

Equate 072.003/072al Rev 2
SPL v20
SPL
SPL Set ID a8daefba-b985-4ef9-b900-e5647324662e
Route
ORAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Citrate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1989-11-11 Until 2023-04-10

Description

Sealed with printed neckband for your protection

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716 *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark FreshBurst Listerine. how2recycle.info Discard Seal, Empty & Replace Cap Plastic Bottle DSP-TN-15000 DSP-MO-34 SDS-TN-15012


Medication Information

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716 *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark FreshBurst Listerine. how2recycle.info Discard Seal, Empty & Replace Cap Plastic Bottle DSP-TN-15000 DSP-MO-34 SDS-TN-15012

Description

Sealed with printed neckband for your protection

Tep

Sealed with printed neckband for your protection

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Directions

adults and children under 12 years if 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
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.

Other Information

cold weather may cloud this product. Its antiseptic propeties are not affected. Store at room temperature (59° -77° F).

Active Ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 0.060%, Thymol 0.064%

Inactive Ingredients

water, alcohol 21.6 %, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow 10, FD&C green 3

Principal Display Panel

NDC: 49035-072-77

equate™

Compare to FreshBurst ®Listerine ®Active Ingredients*

Antiseptic Mouthrinse

Kills Germs that Cause:

  • Plaque
  • Gingivitis
  • Bad breath

ADA Accepted

American Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

Spring Mint

Made in the USA

with 90% OR MORE US PARTS

Factory Certified

500mL (16.9 FL OZ)

Satisfaction Guaranteed

- Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Adverse Reactions Section

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark FreshBurst Listerine.

how2recycle.info

Discard Seal, Empty & Replace Cap

Plastic Bottle

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

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.

Stop Use and Ask A Dentist If

gingivitis, bleeding, or rednss persists for more than 2 weeks


Structured Label Content

Tep (TEP)

Sealed with printed neckband for your protection

Use

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

For this product

Directions

adults and children under 12 years if 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
Do Not Use If (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.

Other Information (Other information)

cold weather may cloud this product. Its antiseptic propeties are not affected. Store at room temperature (59° -77° F).

Active Ingredients (Active ingredients)

Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 0.060%, Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

water, alcohol 21.6 %, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow 10, FD&C green 3

Principal Display Panel

NDC: 49035-072-77

equate™

Compare to FreshBurst ®Listerine ®Active Ingredients*

Antiseptic Mouthrinse

Kills Germs that Cause:

  • Plaque
  • Gingivitis
  • Bad breath

ADA Accepted

American Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

Spring Mint

Made in the USA

with 90% OR MORE US PARTS

Factory Certified

500mL (16.9 FL OZ)

Satisfaction Guaranteed (Satisfaction guaranteed)

- Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Adverse Reactions Section

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark FreshBurst Listerine.

how2recycle.info

Discard Seal, Empty & Replace Cap

Plastic Bottle

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Keep Out of Reach of Children (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.

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding, or rednss persists for more than 2 weeks


Advanced Ingredient Data


Raw Label Data

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