Equate 163.005/163ag

Equate 163.005/163ag
SPL v17
SPL
SPL Set ID e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d
Route
ORAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-05-13

Description

Sealed with printed neckband for your protection. (Do not use if band around cap is broken or missing.)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sealed with printed neckband for your protection. (Do not use if band around cap is broken or missing.)

Use

aids in the prevention of dental cavities

Warning

for this product

Questions

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing 
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
Disclaimers

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

**This product is not intended to replace brushing or flossing.

Adverse Reaction

DISTRIBUTED BY: Walmart Inc. Bentonville, AR 72716

Made in the USA with domestic imported ingredients

Factory Certified

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Other Information
  • store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel

equate™

NDC 49035-163-86

Compare to Listerine ®Total Care Fresh Mint Anticavity Mouthwash Active Ingredient*

Anticavity Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Fresh Mint

Multiple benefits in one:

Helps prevent cavities

Restores enamel

Helps strengthen teeth

Helps kill bad breath germs

Freshens breath

Cleans the entire mouth**

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

Sealed with printed neckband for your protection.

(Do not use if band around cap is broken or missing.)

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.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warning

for this product

Questions

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing 
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
Disclaimers

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

**This product is not intended to replace brushing or flossing.

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY: Walmart Inc. Bentonville, AR 72716

Made in the USA with domestic imported ingredients

Factory Certified

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Other Information (Other information)
  • store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (Principal display panel)

equate™

NDC 49035-163-86

Compare to Listerine ®Total Care Fresh Mint Anticavity Mouthwash Active Ingredient*

Anticavity Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Fresh Mint

Multiple benefits in one:

Helps prevent cavities

Restores enamel

Helps strengthen teeth

Helps kill bad breath germs

Freshens breath

Cleans the entire mouth**

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

Sealed with printed neckband for your protection.

(Do not use if band around cap is broken or missing.)

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.


Advanced Ingredient Data


Raw Label Data

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