Heb 213.002/213ae Rev 2

Heb 213.002/213ae Rev 2
SPL v4
SPL
SPL Set ID c68b0644-685d-4c62-bf5d-3a5bbea3b052
Route
ORAL
Published
Effective Date 2025-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Sorbitol Menthol, Unspecified Form Methyl Salicylate Cetylpyridinium Chloride Saccharin Sodium Poloxamer 407 Polysorbate 20 Propylene Glycol Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous Edetate Calcium Disodium Anhydrous Edetate Disodium Sodium Benzoate Potassium Sorbate Benzyl Alcohol Fd&c Green No. 3 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-21

Description

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity Rinse

Adverse Reactions

MADE WTH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204 100% Guarantee promise


Medication Information

Purpose

Anticavity Rinse

Adverse Reactions

MADE WTH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204

100% Guarantee promise

Description

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Tep

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warning

for this product only

Directions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do now 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 necessay until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash

Questions?

Call 1-888-593-0593

Active Ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Other Information
  • store at room temperature
Inactive Ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Display Panel

Compare to ACT Anticavity

Fluoride Mouthwash

H-E-B

Mint

ANTICAVITY

FLUORIDE

MOUTH RINSE

  • Helps Prevent Cavities
  • Alcohol Free
  • Freshens Breath

IMPORTANT: read directions for proper use.

ADA Accepted

American Dental Association

Helps prevent cavities

18 FL OZ (532 mL)

Keep Out of Reach of Children

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Tep (TEP)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Purpose

Anticavity Rinse

Warning

for this product only

Directions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do now 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 necessay until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash

Questions?

Call 1-888-593-0593

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Adverse Reactions (Adverse reactions)

MADE WTH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204

100% Guarantee promise

Other Information (other information)
  • store at room temperature
Inactive Ingredients (inactive ingredients)

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Display Panel

Compare to ACT Anticavity

Fluoride Mouthwash

H-E-B

Mint

ANTICAVITY

FLUORIDE

MOUTH RINSE

  • Helps Prevent Cavities
  • Alcohol Free
  • Freshens Breath

IMPORTANT: read directions for proper use.

ADA Accepted

American Dental Association

Helps prevent cavities

18 FL OZ (532 mL)

Keep Out of Reach of Children (Keep out of reach of children)

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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